K072783 is an FDA 510(k) clearance for the SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on November 30, 2007, 60 days after receiving the submission on October 1, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K072783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2007 |
| Decision Date | November 30, 2007 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| 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 |