GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
FDA 510(k) clearance K960858 · decided 1996-08-30
Clearance details
- K-number
- K960858
- Device name
- GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
- Applicant
- Greiner America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-01
- Decision date
- 1996-08-30
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 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 |
| Serum Blood Collection Tubes recall (Z-0086-06) | Greiner VACUETTE North America | 2005-10-22 |