Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1415939

FEI Number

1415939

Entity Name

ABBOTT LABORATORIES

City/State/Country

Abbott Park, IL, US

Establishment Address

100 ABBOTT PARK RD., Abbott Park, IL 60064, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alinity i Cyclosporine Whole Blood Precipitation Reagent Kit CELL-DYN EMERALD (LN 09H39-01) ARCHITECT System Accessories ARCHITECT System Alinity s System Accessories Alinity s System ARCHITECT 2nd Generation Testosterone Calibrators (LN 2P13-01) ARCHITECT 2nd Generation Testosterone Controls (LN 2P13-10) Alinity i ROMA (LN 03R7521) ARCHITECT ROMA (LN 6P30-21) ACE Control (LN 06U8210) Cystatin C Controls (LN 06T3210) Alinity i Total B-HCG Controls (LN 07P5110) Alinity i Estradiol Controls (LN 07P5010) FreeStyle Control Solution Alinity i Total T4 Controls (LN 07P9510) Alinity i 2nd Generation Testosterone Controls (LN 07P6810) Alinity i Intact PTH Controls (LN 08P3111) Alinity i Prolactin Controls (LN 07P6610) Alinity i Free T4 Controls (LN 7P7010) Alinity i TSH Controls (LN 07P4810) Alinity i Insulin Controls (LN 04T7510) Alinity i FSH Controls (LN 07P4910) Alinity i HE4 Controls (LN 08P5010) Lipase NG OC Control 2 (LN 04Y8511) Alinity i Progesterone Controls (LN 08P3610) Alinity i Syphilis TP Controls (LN 07P6010) Alinity i 25-OH Vitamin D Controls (LN 08P4512) Alinity i CA 125 II Controls (LN 08P4910) Alinity c ASO Control I (LN 04S0912) Alinity c Ammonia Controls (LN 08P2210) Alinity i CA 15-3 Controls (LN 08P5110) ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10) Alinity i CA 19-9XR Controls (LN 08P3210) Lipase NG OC Control 1 (LN 04Y8510) Alinity i Ferritin Controls (LN 07P6510) Alinity c Lp(a) Control Kit (LN 01R1410) Alinity i Homocysteine Controls (LN 09P2810) Alinity i C-Peptide Controls (LN 09P3610) Alinity i Folate Controls (LN 08P1412) Alinity i B12 Controls (LN 07P6712) Alinity i Anti-Tg Controls (LN 09P3410) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610) Alinity c ASO Control II (LN 04S0913) Alinity i DHEA-S Controls (LN 09P3710) Alinity c Hemoglobin A1c Controls (LN 08P4310) Alinity i Anti-TPO Controls (LN 09P3510) Alinity c Cannabinoids Control 2 Kit (LN 09P5411) Alinity c Cannabinoids Control 1 Kit (LN 09P5410) Alinity i T-Uptake Controls (LN 08P1210) ARCHITECT Insulin Controls (LN 08K4112) Alinity i Free T3 Controls (LN 07P6910) MediSense Control Solution Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110) GFAP Controls (Alinity i, LN 04W1710) UCH-L1 Controls (Alinity i, LN 04W1910) GFAP Controls (ARCHITECT, LN 4W16-10) Alinity i BRAHMS PCT Controls (LN 01R1810) Alere NT-proBNP for Alinity i Controls (LN 04S7911) Alinity i CMV IgG Controls (LN 07P4212) ACE Control (LN 06U8610) UCH-L1 Controls (ARCHITECT, LN 4W18-10) CELL-DYN Emerald 22 (LN 09H5901) Cystatin C Calibrators (LN 06T3201) Alinity i Syphilis TP Calibrator (LN 07P6001) Alinity i Progesterone Calibrators (LN 08P3601) Alinity i 25-OH Vitamin D Calibrators (LN 08P4501) Alinity i Total T4 Calibrators (LN 07P9501) Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801) Alinity i FSH Calibrators (LN 07P4901) Alinity i Free T4 Calibrators (LN 07P7001) Alinity i B12 Calibrators (LN 07P6702) Alinity c UIBC Calibrator Kit (LN 08P4401) Alinity i Prolactin Calibrators (LN 07P6601) Alinity i Total B-hCG Calibrators (LN 07P5101) Alinity i TSH Calibrators (LN 07P4801) Alinity c Hemoglobin A1c Calibrators (LN 08P4301) Alinity i C-Peptide Calibrators (LN 09P3601) Alinity i Ferritin Calibrators (LN 07P6501) Alinity i Intact PTH Calibrators (LN 08P3102) Alinity i Estradiol Calibrators (LN 07P5001) Lipase NG OC Calibrator (LN 04Y8501) Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601) Alinity i LH Calibrators (LN 07P9101) Alinity i Anti-TPO Calibrators (LN 09P3501) Alinity i T-Uptake Calibrators (LN 08P1201) Alinity i Folate Calibrators (LN 08P1402) Alinity c B2-Microglobulin Calibrator (LN 01R0902) Alinity i Insulin Calibrators (LN 04T7501) Alinity c Prealbumin Calibrator Kit (LN 04S0101) Alinity i CA 15-3 Calibrators (LN 08P5101) Alinity i Anti-Tg Calibrators (LN 09P3401) Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002) Alinity i Cortisol Calibrators (LN 08P3301) Alinity c Lp(a) Calibrators (LN 01R1401) Alinity i CA 125 II Calibrators (LN 08P4901) Alinity i DHEA-S Calibrators (LN 09P3701) Alinity i Homocysteine Calibrators (LN 09P2801) Alinity c ASO Calibrator (LN 01R0602) Alinity i Total T3 Calibrators (LN 07P9401) ARCHITECT Insulin Calibrators (LN 08K4103) Alinity i HE4 Calibrators (LN 08P5001) Alinity i CA 19-9XR Calibrators (LN 08P3201) ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01) ARCHITECT Total T3 Calibrators (LN 7K64-02) Alinity i Free T3 Calibrators (LN 07P6901) Alinity i Tacrolimus Calibrators (LN 09P4201) Prealbumin Calibrator (LN 6E57-03) Alinity i Sirolimus Calibrators (LN 09P4101) Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101) Acetaminophen Calibrator (LN 03R7401) Acetaminophen Calibrator (Alinity c, LN 07P5401) UCH-L1 Calibrators (Alinity i, LN 04W1901) GFAP Calibrators (ARCHITECT, LN 4W16-01) Alinity i BRAHMS PCT Calibrators (LN 01R1801) GFAP Calibrators (Alinity i, LN 04W1701) Alere NT-proBNP for Alinity i Calibrators (LN 04S7902) ACE Calibrator (LN 06U8601) UCH-L1 Calibrators (ARCHITECT, LN 4W18-01) ACE Calibrator (LN 06U8201) Alinity i CMV IgG Calibrators (LN 07P4202) ARCHITECT Transplant Pretreatment Tubes (LN 1P06-02) Transplant Pretreatment Tubes (LN 1P06-03) ARCHITECT Sirolimus Reagent Kit (LN 1L76-25) ARCHITECT Sirolimus Calibrators (LN 1L76-01) ARCHITECT Sirolimus Whole Blood Precipitation Reagent (LN 1L76-55) Alinity i Sirolimus Whole Blood Precipitation Reagent (LN 09P4140) Alinity i Sirolimus Reagent Kit (LN 09P4120) Emerald 22 Autoloader Analyzer (LN 04R1301) Transplant Pretreatment Tubes (LN 01P0603) ARCHITECT Tacrolimus Whole Blood Precipitation Reagent (LN 01L7755) Alinity i Tacrolimus Reagent Kit (LN 09P4220) ARCHITECT Tacrolimus Reagent Kit (LN 01L7725) ARCHITECT Transplant Pretreatment Tubes (LN 01P0602) ARCHITECT Tacrolimus Calibrators (LN 01L7701) Alinity i Tacrolimus Whole Blood Precipitation Reagent (LN 09P4240) Alinity n Sample Tip (LN 0TN43-01) Alinity n Amplification Vessel (LN 0TN41-01) Alinity n Wash Vessel (LN 0TN42-01) Alinity m Transport Tube Alinity m Transport Tube Pierceable Capped Alinity m LRV Tube Alinity m Pierceable Cap Alinity m Aliquot Tube Alinity m Bottle for Ethanol Use Alinity n Eluate Tip (LN 0TN44-01) Alinity n Lysis Tube and Tip (LN 0TN40-01)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2019-12-15
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	1977-12-13
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2016-12-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-19
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2012-09-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	Class 2	866.6050	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-11-22
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2015-10-13
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-05-03
NRP	Sirolimus Test System	Clinical Toxicology	Class 2	862.3840	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-03-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
MLM	Enzyme Immunoassay, Tracrolimus	Clinical Chemistry	Class 2	862.1678	2019-09-25
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081992	Siemens Healthcare Diagnostics, Inc.	DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108	2008-08-05
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

Registration Number	Establishment Name	Location
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
2517506	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NEWARK, DE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1415939. Last updated year: 2026. Please use registration number 1415939 when referencing this establishment in official correspondence.