FDA Registration
Active
🇺🇸 United States
LABOTEK GROUP CORP
Reg #: 3010194621
·
FEI: 3010194621
·
Expires 2026
Products
56
Proprietary Names
13
Establishment Types
1
Classifications
56
Registration Details
- Registration Name
- LABOTEK GROUP CORP
- Registration Number
- 3010194621
- FEI Number
- 3010194621
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- CARR 174 KM 4.5 BO JUAN SANCHEZ
- City
- Bayamon
- State
- PR
- ZIP
- 00956
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170136
Owner / Operator
- Firm Name
- LABOTEK GROUP CORP.
- Operator Number
- 10044096
- Address
- CARR 174 KM 4.5 BO JUAN SANCHEZ
- City
- Bayamon
- State
- PR
- Postal Code
- 00956
- Country
- US
- Correspondent
- MARISOL AROCHO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2019-09-26 |
| Unit, Drying | JRJ | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Microtome, Ultra | IDM | Class 1 | Pathology | No | 2019-09-26 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2019-09-26 |
| Pipette, Quantitative, Hematology | GJG | Class 1 | Hematology | No | 2019-09-26 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-03-12 |
| Cuvette, Thermostated | JRI | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2019-09-26 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-09-26 |
| Micro Mixer | JRB | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Microtome, Sliding | KFL | Class 1 | Pathology | No | 2019-09-26 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2019-09-26 |
| Platelet Counting, Manual | GLG | Class 1 | Hematology | No | 2019-09-26 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2019-09-26 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2023-03-01 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-03-12 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-03-12 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2019-09-26 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-12-07 |
| Test, Erythrocyte Sedimentation Rate | JPH | Class 1 | Hematology | No | 2019-09-26 |
| Kit, Mycoplasma Detection | KIW | Class 1 | Hematology | No | 2019-09-26 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2019-09-26 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Shaker/Stirrer | JRQ | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | Class 1 | Pathology | No | 2019-09-26 |
| Hemocytometer | GHO | Class 1 | Hematology | No | 2019-09-26 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2019-09-26 |
| Test, Thromboplastin Generation | GKQ | Class 1 | Hematology | No | 2019-09-26 |
| Hand-Tally, Differential | GKM | Class 1 | Hematology | No | 2019-09-26 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2019-09-26 |
| Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | PER | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Condensers, Microscope | KEI | Class 1 | Pathology | No | 2019-09-26 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2019-09-26 |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 2019-09-26 |
| Blender/Mixer | JRO | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Bottle, Roller, Tissue Culture | KJC | Class 1 | Hematology | No | 2019-09-26 |
| Mixer, Blood Tube | GLE | Class 1 | Clinical Chemistry | No | 2019-09-26 |
| Fixative, Formalin-Containing | LDY | Class 1 | Pathology | No | 2019-09-26 |
| Kit, Culture, Chromosome | KIQ | Class 1 | Hematology | No | 2019-09-26 |
| Solution, Decalcifier, Acid Containing | KDX | Class 1 | Pathology | No | 2019-09-26 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2019-09-26 |
| Formaldehyde (Formalin, Formol) | IGG | Class 1 | Pathology | No | 2019-09-26 |
| Pipette, Pasteur | GJW | Class 1 | Hematology | No | 2019-09-26 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2024-04-30 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2019-09-26 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2019-09-26 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | Class 1 | Pathology | No | 2019-09-26 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2024-03-12 |
| Tube, Sedimentation Rate | GHC | Class 1 | Hematology | No | 2019-09-26 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | KDW | Class 1 | Pathology | No | 2019-09-26 |
| Pipette, Diluting | GGY | Class 1 | Hematology | No | 2019-09-26 |
| Cells, Animal And Human, Cultured | KIR | Class 1 | Hematology | No | 2019-09-26 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | Class 1 | Clinical Chemistry | No | 2019-09-26 |
Proprietary Names
LABOTEK
Labotek Spot Bandage
VacSure Uni-Band
Universal Bandage
VacSure Disposable TPE Tourniquet
Tourniquet
Powder Free Glove
Tested for Use with Chemotherapy Drugs
TOUCH Chemo Tested Nitrile Exam Glove
VACSURE Safety Multi-Sample Blood Collection Needle For Single Use
VACSURE Safety Multi-Sample Blood Collection Needle with Holder For Single Use
VacSure EZ CARE Pressure Activate Safety Lancet
VacSure Sharp Containers (1QT, 5QT, 2GAL, 3GAL, 8GAL, 12GAL, 18GAL)
Establishment Types
Repack or Relabel Medical Device