GREINER VACUETTE BLOOD COLLECTION TUBE
FDA 510(k) clearance K971239 · decided 1997-05-12
Clearance details
- K-number
- K971239
- Device name
- GREINER VACUETTE BLOOD COLLECTION TUBE
- Applicant
- Greiner America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-02
- Decision date
- 1997-05-12
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JKA
- 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 |
|---|---|---|
| VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-blac recall (Z-0733-2024) | Greiner Bio-One North America, Inc. | 2024-01-16 |