GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
FDA 510(k) clearance K960857 · decided 1996-08-30
Clearance details
- K-number
- K960857
- Device name
- GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & 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 |
|---|---|---|
| LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 2 recall (Z-1081-2012) | Greiner Bio-One North America, Inc. | 2012-02-22 |
| Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North Ame recall (Z-0623-2011) | Greiner Bio-One North America, Inc. | 2010-12-16 |
| VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 gre recall (Z-0215-2009) | Greiner Bio-One North America, Inc. | 2008-11-07 |