K081929 is an FDA 510(k) clearance for the VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Greiner Bio-One North America, Inc. (Baldwin, US). The FDA issued a Cleared decision on December 16, 2008, 162 days after receiving the submission on July 7, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K081929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2008 |
| Decision Date | December 16, 2008 |
| Days to Decision | 162 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |