GREINER VACUETTE BLOOD COLLECTION TUBE
FDA 510(k) clearance K983952 · decided 1998-12-28
Clearance details
- K-number
- K983952
- Device name
- GREINER VACUETTE BLOOD COLLECTION TUBE
- Applicant
- Greiner Meditech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-05
- Decision date
- 1998-12-28
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bel Air, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog N recall (Z-0571-2026) | Greiner Bio-One North America, Inc. | 2025-11-19 |
| VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridg recall (Z-2375-2024) | Greiner Bio-One North America, Inc. | 2024-07-17 |