LABOTEK GROUP CORP

FDA Device Registration & Listing · Bayamon, PR, US · Registration 3010194621

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
3010194621
FEI Number
3010194621
Entity Name
LABOTEK GROUP CORP
City/State/Country
Bayamon, PR, US
Establishment Address
CARR 174 KM 4.5 BO JUAN SANCHEZ, Bayamon, PR 00956, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
LABOTEK GROUP CORP. (Owner Number: 10044096)
Owner / Operator Contact Address
CARR 174 KM 4.5 BO JUAN SANCHEZ, Bayamon, PR 00956, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK Labotek Spot Bandage VacSure Uni-Band Universal Bandage LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK VacSure Disposable TPE Tourniquet Tourniquet Powder Free Glove Tested for Use with Chemotherapy Drugs TOUCH Chemo Tested Nitrile Exam Glove LABOTEK VACSURE Safety Multi-Sample Blood Collection Needle For Single Use VACSURE Safety Multi-Sample Blood Collection Needle with Holder For Single Use LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK LABOTEK

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2019-09-26
JRJ Unit, Drying Clinical Chemistry Class 1 862.2050 2019-09-26
IDM Microtome, Ultra Pathology Class 1 864.3010 2019-09-26
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2019-09-26
GJG Pipette, Quantitative, Hematology Hematology Class 1 864.6160 2019-09-26
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2019-09-26
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-03-12
JRI Cuvette, Thermostated Clinical Chemistry Class 1 862.2050 2019-09-26
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2019-09-26
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2019-09-26
JRB Micro Mixer Clinical Chemistry Class 1 862.2050 2019-09-26
KFL Microtome, Sliding Pathology Class 1 864.3010 2019-09-26
KEW Slides, Microscope Pathology Class 1 864.3010 2019-09-26
GLG Platelet Counting, Manual Hematology Class 1 864.6160 2019-09-26
IDO Microtome, Rotary Pathology Class 1 864.3010 2019-09-26
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2023-03-01
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-03-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-03-12
KET Filters, Cell Collection, Tissue Processing Pathology Class 1 864.3010 2019-09-26
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-12-07
JPH Test, Erythrocyte Sedimentation Rate Hematology Class 1 864.6700 2019-09-26
KIW Kit, Mycoplasma Detection Hematology Class 1 864.2360 2019-09-26
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2019-09-26
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2019-09-26
JRQ Shaker/Stirrer Clinical Chemistry Class 1 862.2050 2019-09-26
MPQ Container, Specimen, Urine, Drugs Of Abuse, Over The Counter Pathology Class 1 864.3260 2019-09-26
GHO Hemocytometer Hematology Class 1 864.6160 2019-09-26
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2019-09-26
GKQ Test, Thromboplastin Generation Hematology Class 1 864.7900 2019-09-26
GKM Hand-Tally, Differential Hematology Class 1 864.6160 2019-09-26
JRC Micro Pipette Clinical Chemistry Class 1 862.2050 2019-09-26
IDZ Cassettes, Tissue Pathology Class 1 864.3010 2019-09-26
PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis Clinical Chemistry Class 1 862.2750 2019-09-26
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2019-09-26
KEI Condensers, Microscope Pathology Class 1 864.3600 2019-09-26
KST System, Blood Collection, Vacuum-Assisted, Manual Hematology Class 1 864.9125 2019-09-26
DGR Whole Human Serum, Antigen, Antiserum, Control Immunology Class 1 866.5700 2019-09-26
JRO Blender/Mixer Clinical Chemistry Class 1 862.2050 2019-09-26
KJC Bottle, Roller, Tissue Culture Hematology Class 1 864.2240 2019-09-26
GLE Mixer, Blood Tube Clinical Chemistry Class 1 862.2050 2019-09-26
LDY Fixative, Formalin-Containing Pathology Class 1 864.4010 2019-09-26
KIQ Kit, Culture, Chromosome Hematology Class 1 864.2260 2019-09-26
KDX Solution, Decalcifier, Acid Containing Pathology Class 1 864.4010 2019-09-26

Official Correspondent

MARISOL AROCHO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LABOTEK GROUP CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-2020 Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands 1
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Z-0039-2012 Richard-Allan Scientific Company 1
Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.
Z-0030-2014 Perkin Elmer Health Sciences, Inc. 2
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010194621. Last updated year: 2026. Please use registration number 3010194621 when referencing this establishment in official correspondence.
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