Beckman Coulter, Inc.

FDA Device Registration & Listing · West Sacramento, CA, US · Registration 2919016

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2919016
FEI Number
2919016
Entity Name
Beckman Coulter, Inc.
City/State/Country
West Sacramento, CA, US
Establishment Address
1584 Enterprise Blvd, West Sacramento, CA 95691, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BECKMAN COULTER, INC. (Owner Number: 2050012)
Owner / Operator Contact Address
250 S. Kraemer Blvd, --, Brea, CA 92821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K172912
PMA Number
N/A

All Registered Proprietary Names

MicroScan MICroSTREP plus Panels - Gatifloxacin MicroScan MICroSTREP plus Panels - Azithromycin MicroScan MICroSTREP plus Panels - Clindamycin MicroScan MICroSTREP plus Panels - Moxifloxacin MicroScan MICroSTREP plus Panels - Tetracycline MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin MicroScan Dried Gram Negative MIC/Combo Panels - Ampicillin MicroScan Dried Gram Positive MIC/Combo Panels - Synercid MicroScan MICroSTREP plus Panels - Penicillin MicroScan HNID Indole Reagent 30ml MicroScan 10% Ferric Chloride 250ml MicroScan Rapid Neg ID Panel Type 3 MicroScan HNID Panel MicroScan Kovacs Reagent 250ml MicroScan 0.8% Sulfanilic Acid 30ml MicroScan Rapid Neg ID Panel Type 4 MicroScan 0.5% N,N-Dimethylalphanaphthylamine 30ml MicroScan Dried Gram Negative Combo Panels MicroScan 0.5% N,N-Dimethylalphanaphthylamine 250ml MicroScan 40% Potassium Hydroxide 30ml MicroScan Mineral Oil 250ml MicroScan 40% Potassium Hydroxide 250ml MicroScan Kovacs Reagent 30ml MicroScan 0.8% Sulfanilic Acid 250ml MicroScan Mineral Oil 60ml MicroScan Peptidase 250ml MicroScan Alpha Naphthol 1.5g MicroScan Rapid Indole Reagent-F 30ml MicroScan 10% Ferric Chloride 30ml MicroScan Neg ID Panel Type 2 MicroScan Peptidase 30ml VITEK REVEAL BC GN01-AST MicroScan MICroSTREP plus Panels - Cefuroxime MicroScan MICroSTREP plus Panels - Ceftriaxone MicroScan Dried Gram Positive MIC/Combo Panels - Erythromycin MicroScan MICroSTREP plus Panels - Ampicillin MicroScan MICroSTREP plus Panels - Azithromycin MicroScan MICroSTREP plus Panels - Linezolid MH BROTH with 3% LHB MicroScan Dried Gram-Negative MIC/Combo Panels - Aztreonam MicroScan Dried Gram-Negative MIC/Combo Panels - Ciprofloxacin MicroScan Dried Gram Positive MIC/Combo Panels - Meropenem MicroScan Dried Gram Negative MIC/Combo Panels - Cefepime MicroScan Dried Gram Positive MIC/Combo Panels - Cefepime MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefepime MicroScan MICroSTREP plus Panels - Trimethoprim/Sulfamethoxazole MicroScan MICroSTREP plus Panels - Vancomycin MicroScan MICroSTREP plus Panels - Cefotaxime MicroScan Dried Gram Negative MIC/Combo Panels - Cefpodoxime MicroScan autoSCAN-4 MicroScan MICroSTREP plus Panels - Erythromycin MicroScan MICroSTREP plus Panels - Ampicillin MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin MicroScan MICroSTREP plus Panels - Clindamycin MicroScan MICroSTREP plus Panels - Chloramphenicol MicroScan Dried Gram Positive MIC/Combo Panels MicroScan Dried Gram Negative MIC/Combo Panels MicroScan Dried Gram Negative MIC/Combo Panels- Minocycline MicroScan Dried Gram-Negative MIC/Combo Panels - Levofloxacin MicroScan Dried Gram Positive MIC/Combo Panels - Ampicillin MicroScan Dried Gram Negative MIC/Combo Panels - Cefotaxime MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime / Clavulanic acid MicroScan Dried Gram Negative MIC/Combo Panels - Cefotaxime / Clavulanic acid MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Cefotaxime MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Ceftazidime MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Ceftriaxome MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Cefpodoxime MicroScan WalkAway-40 plus (PN B1018-283) MicroScan WalkAway-96 plus (PN B1018-284) DxM 1096 MicroScan WalkAway Instrument (PN B1018-496) DxM 1040 MicroScan WalkAway Instrument (PN B1018-440) MicroScan MICroSTREP plus Panels with Tetracycline MicroScan MICroSTREP plus Panels - Cefepime MicroScan Dried Gram Positive MIC/Combo Panels - Penicillin MicroScan MICroSTREP plus Panels - Meropenem MicroScan MICroSTREP plus Panels -Cefotaxime MicroScan MICroSTREP plus Panels - Cefaclor MicroScan HTM BROTH MicroScan Rapid Anaerobe ID Panel MicroScan MICroSTREP plus Panels - Azithromycin D31063 MicroScan LabPro Connect V54 System DVD Kit (MR) D31061 MicroScan LabPro Connect V54 System DVD Kit (JP) D31050 MicroScan LabPro Connect V54 System (FMR), Electronic D31062 MicroScan LabPro V54 System DVD Kit (MR) D31065 MicroScan LabPro Connect V54 System DVD Kit (FMR) D31045 MicroScan LabPro V54 System (MR), Electronic D31064 MicroScan LabPro V54 System DVD Kit (FMR) D23504 MicroScan HighFlexX Software x2.9.2, Electronic C90683 LabPro V5 Panel Update 10 (FMR), Electronic C24164 MicroScan LabPro V5 System DVD Kit (JP) C24166 MicroScan LabPro V5 System DVD Kit (MR) C90685 MicroScan LabPro V5 Panel Update 10 DVD Kit (FMR) C24165 MicroScan LabPro Connect V5 System DVD Kit (JP) D15062 MicroScan LabPro Connect v52 System (JP), Electronic D14981 MicroScan LabPro v52 System (JP), Electronic C38722 MicroScan LabPro Connect V5 System DVD Kit (FMR) D31041 MicroScan LabPro V54 System (JP), Electronic D31060 MicroScan LabPro V54 System DVD Kit (JP) D31042 MicroScan LabPro Connect V54 System (JP), Electronic C54389 MicroScan HighFlexX Software v2.9, Electronic D31046 MicroScan LabPro Connect V54 System (MR), Electronic B1018-340R MicroScan WA 40 Plus Reconditioned C38721 MicroScan LabPro V5 System DVD Kit (FMR) B1018-396R MicroScan WA 96 Plus Reconditioned C24167 MicroScan LabPro Connect V5 System DVD Kit (MR) D31049 MicroScan LabPro V54 System (FMR), Electronic MicroScan MICroSTREP plus Panels - Amoxicillin/Clavulanic acid MicroScan Pos Combo 2T MICroSTREP Plus Panel Type 5 MicroScan Neg BP Combo Panel Type 49 MicroScan Dried Gram Negative Breakpoint Combo Panel Type 42 MicroScan MICroFAST 7J MicroScan Neg Combo EN 2J MicroScan Dried Gram Pos BPCombo 3.2J (M) MicroScan Dried Gram Negative Combo Panel Type 58 MicroScan Dried Gram Negative Combo Panel Type 54 MicroScan Neg MIC EN 2J MicroScan Neg Combo NF 3T MicroScan Neg Breakpoint Combo 50 MicroScan Neg Combo NF 3J MicroScan Dried Gram Positive Combo Panel Type 31 MicroScan Neg MIC EN 52 MicroScan Pos MIC 2J MicroScan Dried Gram Positive Combo Panel Type 38 MicroScan Pos Combo Panel Type 41 MICroSTREP Plus Panel Type 3 MicroScan Pos Combo Panel Type 42 MicroScan Neg Urine Combo Panel Type 69 MicroScan Pos MIC E 37 MicroScan Neg Combo NF 2J MicroScan Neg Entero Combo Panel Type 70 MicroScan Neg MIC 2J MicroScan Neg Bkpt Combo Panel Type 48 MicroScan Pos MIC Panel Type 33 MicroScan Pos MIC STA 35 MicroScan Neg Combo OUT 2J MicroScan Dried Gram Positive Combo Panel Type 32 MicroScan Dried Gram Negative Urine Combo Panel Type 52 MicroScan Neg Combo IN 2J MicroScan Dried Gram Negative BP Combo Panel Type 46 MicroScan Neg Combo EN 2T MicroScan MICroSTREP plus Panel Type 6 MicroScan Dried Gram Negative Urine Combo Panel Type 57 MicroScan Dried Gram Pos BP Combo 3.2J MicroScan Dried Gram Positive BP Combo Panel Type 28 MicroScan Dried Gram Positive Combo Panel Type 37 MicroScan Neg Combo Panel Type 72 MicroScan Neg Non Entero Combo Panel Type 71 MicroScan MICroFAST Panel Type 6J MicroScan Dried Gram Positive BP Combo Panel Type 32 MicroScan Negative MIC EN 47 MicroScan Neg Combo Panel Type 66 MicroScan Neg MIC Panel Type 43 MicroScan Dried Gram Positive MIC Panel Type 32 MicroScan Pos Combo Panel Type 39 MicroScan Neg MIC Panel Type 44 MicroScan Dried Gram Negative Urine Combo Panel Type 59 MicroScan Pos Combo 1J MicroScan Neg MIC EN 3J MicroScan Neg Combo 82 MicroScan Neg MIC NF 1J MicroScan Neg Combo Panel Type 63 MicroScan Pos Breakpoint Combo 1J MicroScan Dried Gram Pos Combo Panel Type 3.1C MicroScan Neg Combo EN 3J MicroScan Negative MIC NF 50 MicroScan Pos MIC 1J MicroScan Dried Gram Pos Combo Panel Type 3.1J MicroScan Neg Breakpoint Combo 4J MicroScan Neg Combo 83 MicroScan Neg Breakpoint Combo 2J MicroScan Dried Gram Negative MIC Panel Type 40 MicroScan Neg Combo EN 2C MicroScan Neg Urine Combo 81 MicroScan Neg Combo NF 3J (M) MicroScan Neg MIC EN 51 MicroScan Dried Gram Negative Combo Panel Type 53 MicroScan Pos MIC STA 36 MicroScan Neg Combo EN 4J MicroScan Neg Combo EN 4J (M) MicroScan MSF FAST MIC Panel Type 2 MicroScan Neg Multidrug Resistant MIC 1 MicroScan MSF POS MIC Panel Type 2 MicroScan MSF Neg/Pos ID Panel Type 2 MicroScan MSF NEG MIC Panel Type 2 MicroScan Neg MIC 57 MicroScan Neg MDR Combo 100 MicroScan Neg MIC Panel Type 63 MicroScan Neg Combo 99 MicroScan Pos Combo Panel Type 49 MicroScan Negative MIC NF 64 MicroScan Pos MIC 40 MicroScan Neg Combo 96 MicroScan Neg Combo 94 MicroScan Neg Combo 97 MicroScan Neg Uriine Combo 95 MicroScan Neg MIC 61 MicroScan Neg Mutidrug Resistant MIC 2 MicroScan Neg Breakpoint Combo 53 MicroScan Neg MIC Panel Type 62 MicroScan Pos Combo Panel Type 48 MicroScan Neg Urine Combo Panel Type 98 MicroScan MSF Neg/Pos ID Type 2 Panel MicroScan Pos Breakpoint Combo Panel Type 33 MicroScan Pos MIC Panel Type 28 MicroScan Neg BP Combo 1J(M) MicroScan Neg Breakpoint Combo Panel Type 42 MicroScan Pos Breakpoint Combo Panel Type 28 MicroScan MSF Neg MIC Panel Type 2 MicroScan Dried Gram Positive MIC/Combo Panels - Tigecycline MicroScan Dried Gram Positive MIC/Combo Panels - Linezolid D23352 MicroScan LabPro V53 Panel Update 11 (US), Electronic D33604 MicroScan LabPro V53 Data Delivery 07 (US), Electronic D23354 MicroScan LabPro V53 Panel Update 11 DVD Kit (US) MicroScan LabPro Data Management System MicroScan LabPro Connect MicroScan LabPro MBT D23825, MicroScan LabPro Connect V53 System (US), Electronic D23829 MicroScan LabPro Connect V53 System DVD Kit (US) D23824 MicroScan LabPro V53 System (US), Electronic D23828 MicroScan LabPro V53 System DVD Kit (US) MicroScan Dried Gram Positive MIC/Combo Panels - Moxifloxacin MicroScan Dried Gram Negative MIC/Combo Panels - Moxifloxacin MicroScan Turbidity Meter MicroScan Dried Gram Negative MIC/Combo Panels - Eravacycline MicroScan ESBL Plus ESBL Confirmation - Ceftriaxone MicroScan Dried Gram Positive MIC/Combo Panels - Ceftriaxone MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime MicroScan Dried Gram Negative MIC/Combo Panels - Ceftriaxone MicroScan ESBL Plus ESBL Confirmation - Aztreonam MicroScan Dried Gram Negative MIC/Combo Panels - Aztreonam MicroScan ESBL Plus ESBL Confirmation - Ceftazidime MicroScan MICroSTREP plus Panel - Clarithromycin MicroScan Dried Gram Negative MIC/Combo Panels - Ertapenem MicroScan Dried Gram Positive MIC/Combo Panels - Norfloxacin MicroScan Dried Gram Negative MIC/Combo Panels - Norfloxacin MicroScan Dried Gram Positive MIC/Combo Panels - Cefoxitin Screen Well MicroScan MICroSTREP plus Panels - Erythromycin MicroScan Dried Gram-Negative MIC/Combo Panels - Meropenem MicroScan Dried Gram Negative MIC/Combo Panels - Cefuroxime VITEK REVEAL BC GN02-AST MicroScan MICroSTREP plus Panels - Daptomycin MicroScan MICroSTREP plus Panels - Meropenem MicroScan Dried Gram-Negative MIC/Combo Panels - Meropenem MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime/Avibactam MicroScan Dried Gram Positive MIC/Combo Panels - Daptomycin MicroScan Rapid Pos ID Panel Type 2 MicroScan Pos ID Panel Type 3 MicroScan Dried Gram Positive Combo Panels MicroScan Dried Gram Positive MIC/Combo Panels- Azithromycin MicroScan Dried Gram Positive MIC/Combo Panels- Rifampin MicroScan Dried Gram Negative MIC/Combo Panels - Ticarcillin/K. Clavulanate MicroScan Dried Gram Negative ESBL Confirmation Panel - Imipenem MicroScan Dried Gram Negative MIC/Combo Panels - Cefotetan MicroScan Dried Gram Positive MIC/Combo Panels- Amoxicillin/K Clavulanate MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefotetan MicroScan Dried Gram Negative MIC/Combo Panels - Imipenem MicroScan Dried Gram Positive MIC/Combo Panels- Cefazolin MicroScan Dried Gram Positive MIC/Combo Panels- Imipenem MicroScan Dried Gram Positive MIC/Combo Panels- Cefuroxime MicroScan MICroSTREP plus Panels - Penicillin MicroScan Dried Gram Negative MIC/Combo Panels - Piperacillin/Tazobactam MicroScan Dried Gram Positive MIC/Combo Panels - Inducible Clindamycin Test MicroScan Rapid Yeast ID Panel MicroScan MICroSTREP plus Panels - Chloramphenicol MicroScan MICroSTREP plus Panels - Tetracycline MicroScan Dried Gram-Positive MIC/Combo Panels with Ceftaroline D03455 MicroScan LabPro v5 EU SMU Predictive Susceptibility (MR), Electronic C79969 MicroScan LabPro V4.43/4.44 Panel Update-08 DVD Kit (MR) D11977 MicroScan LabPro v50 Data Delivery-05, MR, Electronic C82964 MicroScan LabPro v5 Maintenance Update 1 W/Panel Update 09 DVD Kit (MR) D19723 MicroScan LabPro v50 Data Delivery-06 (FMR), Electronic C66901 MicroScan LabPro V5 Panel Update - 07 DVD Kit (Japan) D11478 MicroScan LabPro V4.45/V5 Data Delivery 4 (JP) C66902 MicroScan LabPro V5 Update - 07 DVD System Kit (Japan) C90683 MicroScan LabPro V5 Panel Update 10 (FMR), Electronic C90384 MicroScan LabPro V5 Maintenance Update 1 W/Panel Update 09 (MR), Electronic D12596 MicroScan LabPro V4_V5 Maintenance Update 05 (MR, FMR), Electronic D12427 MicroScan LabPro V4_V5 Maintenance Update 05 (US), Electronic D05946 MicroScan LabPro v50 Data Delivery-03, Electronic D12429 MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit (US, FMR, MR) MicroScan Dried Gram Negative MIC/Combo Panels - Levofloxacin MicroScan RENOK Rehydrator / Inoculator System (PN B1018-14) MicroScan RENOK Disposable R-Inoculator Sets MicroScan RENOK Disposable D-Inoculator Sets MicroScan MICroSTREP plus Panels - Levofloxacin MicroScan Dried Gram Negative MIC/Combo Panels - Ceftolozane/Tazobactam MicroScan Yeast Turbidity Standard 3ml MicroScan 05N Sodium Hydroxide 250ml MicroScan 05N Sodium Hydroxide 30ml MicroScan Dried Gram-Negative MIC/Combo Panels - Ceftazidime MicroScan Dried Gram Negative ESBL Confirmation Panel MicroScan Dried Gram Positive MIC/Combo Panels MicroScan Dried Gram Negative MIC/Combo Panels MicroScan Dried Gram Negative MIC/Combo Panels - Amoxicillin/K Clavulanate MicroScan Prompt Inoculation System-D MicroScan Dried Gram Negative MIC/Combo Panels - Cefepime MicroScan Dried Gram Negative MIC/Combo Panels - Cefixime MicroScan Dried Gram-Positive MIC/Combo Panels - Daptomycin MicroScan Dried Gram Positive MIC/Combo Panels - Levofloxacin MicroScan ESBL plus ESBL Confirmation Panel - Meropenem MicroScan Dried Gram Negative MIC/Combo Panels - Meropenem MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin MicroScan MICroSTREP plus Panels - Ceftriaxone MicroScan ESBL plus ESBL Confirmation Panel - Ceftazidime MicroScan ESBL plus ESBL Confirmation Panel - Ceftazidime / Clavulanic acid MicroScan ESBL plus ESBL Confirmation Panel - Cefotaxime / Calvulanic acid MicroScan ESBL plus ESBL Confirmation Panel - Cefotaxime MicroScan Dried Gram Positive MIC/Combo Panels - Erythromycin MicroScan Dried Gram Negative MIC/Combo Panels - Ciprofloxacin-S

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-19
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-04-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-19
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-04-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-15
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2016-04-15
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-04-15
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-04-15
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-04-21
LQM Gram Negative Identification Panel Microbiology Class 1 866.2660 2015-02-24
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2023-04-26
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-21
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-19
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-04-15
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2025-07-21
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2025-07-21
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-07-21
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2025-07-21
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2020-07-06
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2020-07-06
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2020-07-06
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2020-07-06
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-21
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-21
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-19
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2017-11-14
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2017-11-14
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2017-11-14
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2017-11-14
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2020-07-06
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2020-07-06
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2020-07-06
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2020-07-06
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2021-05-19
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2021-05-19
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2021-05-19
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2021-05-19
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2021-05-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-15
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-21
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-04-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-21
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2021-03-09
JSP Kit, Anaerobic Identification Microbiology Class 1 866.2660 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2024-10-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-04-21
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-24
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2020-10-20
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 1992-12-03
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-04-24
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2019-04-24
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2019-04-24
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2019-04-24
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-03-05
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-03-05
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-04-19
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2019-11-14
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2019-11-14
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2019-11-14
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-11-14
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Microbiology Class 2 866.1650 2024-07-29
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2024-07-29
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-02-23
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-02-23
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2020-07-06
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2020-07-06
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2020-07-06
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2020-07-06
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2018-01-23
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JXB Kit, Identification, Yeast Microbiology Class 1 866.2660 2015-02-23
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LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-02-23
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US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BECKMAN COULTER, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004198394 BECKMAN COULTER, INC. INDIANAPOLIS, IN, US
3021394862 Beckman Coulter Biomedical GmbH Baierbrunn Bavaria, DE
3008629785 Beckman Coulter, Inc. Hebron, KY, US
3006677029 Beckman Coulter Biomedical GmbH Munchen Bavaria, DE
3003244710 Beckman Coulter Biotechnology (Suzhou) Co., Ltd Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032162 Beckman Coulter, Inc. ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 2003-08-08
K010508 Pasco Laboratories, Inc. PASCO MIC AND MIC/ID PANELS 2001-04-23
K111394 Siemens Healthcare Diagnostics, Inc. MICROSCAN MICROSTEP 2011-06-22
K944753 Radiometer America, Inc. SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP 1995-02-24
K033458 Becton, Dickinson & CO BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST 2004-05-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0170-2015 Siemens Healthcare Diagnostics, Inc. 2
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0025-2025 Beckman Coulter, Inc. 1
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2919016. Last updated year: 2026. Please use registration number 2919016 when referencing this establishment in official correspondence.
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