GREINER VACUETTE BLOOD COLLECTION TUBE
FDA 510(k) clearance K971221 · decided 1997-05-02
Clearance details
- K-number
- K971221
- Device name
- GREINER VACUETTE BLOOD COLLECTION TUBE
- Applicant
- Greiner America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-02
- Decision date
- 1997-05-02
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- GIM
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lake Mary, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 recall (Z-0408-2026) | Greiner Bio-One North America, Inc. | 2025-10-28 |
| VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ri recall (Z-1534-2021) | Greiner Bio-One North America, Inc. | 2021-05-06 |
| 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., recall (Z-2154-2012) | Greiner Bio-One North America, Inc. | 2012-08-07 |
| Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap- recall (Z-1498-06) | Greiner Bio-One North America, Inc. | 2006-09-13 |
| Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 2 recall (Z-1331-04) | Greiner VACUETTE North America | 2004-08-10 |