Data / Medical devices / United States / Labotek Group Corp
Labotek Group Corp: FDA-registered device maker in Bayamon, PR, United States, 4 510(k) clearances
Labotek Group Corp is registered with the FDA (registration 3010194621) in Bayamon, PR, United States. It lists 56 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010194621
- Address
- Carr 174 KM 4.5 Bo Juan Sanchez, Bayamon, PR, United States, 00956
- Owner or operator
- LABOTEK GROUP CORP. (10044096)
- Roles
- Repackager or relabeler
- First device listed
- September 26, 2019
- Registered through
- 2026
- Brand names listed
- LABOTEK, Labotek Spot Bandage, Powder Free Glove, TOUCH Chemo Tested Nitrile Exam Glove, Tested for Use with Chemotherapy Drugs, Tourniquet, Universal Bandage, VACSURE Safety Multi-Sample Blood Collection Needle For Single Use and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Adaptor, Holder, Syringe | IQG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | PER | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blender/Mixer | JRO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bottle, Roller, Tissue Culture | KJC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cassettes, Tissue | IDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cells, Animal And Human, Cultured | KIR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Condensers, Microscope | KEI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | KDW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Coverslips, Microscope Slide | KES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cuvette, Thermostated | JRI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dish, Tissue Culture | KIZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Filters, Cell Collection, Tissue Processing | KET | 1 | Repackager or relabeler | accessdata.fda.gov |
| Fixative, Formalin-Containing | LDY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Formaldehyde (Formalin, Formol) | IGG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Formalin, Neutral Buffered | IFP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hand-Tally, Differential | GKM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemocytometer | GHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Culture, Chromosome | KIQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Mycoplasma Detection | KIW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Micro Mixer | JRB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microtome, Rotary | IDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microtome, Sliding | KFL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microtome, Ultra | IDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mixer, Blood Tube | GLE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pipette, Diluting | GGY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pipette, Pasteur | GJW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pipette, Quantitative, Hematology | GJG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Platelet Counting, Manual | GLG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shaker/Stirrer | JRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Solution, Decalcifier, Acid Containing | KDX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Erythrocyte Sedimentation Rate | JPH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Thromboplastin Generation | GKQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Sedimentation Rate | GHC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Drying | JRJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| October 3, 2022 | K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | FMK | Substantially Equivalent | Shandong Lianfa Medical Plastic Products Co. , Ltd. | accessdata.fda.gov |
| November 4, 2021 | K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | JKA | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 3, 2019 | K180984 | Maxcon Sharps Container | MMK | Substantially Equivalent | Ningbo Maxcon Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.