K063357 is an FDA 510(k) clearance for the MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES. 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 July 10, 2007, 245 days after receiving the submission on November 7, 2006.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K063357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2006 |
| Decision Date | July 10, 2007 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| 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 |