K941159 is an FDA 510(k) clearance for the DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on May 19, 1994, 69 days after receiving the submission on March 11, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K941159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1994 |
| Decision Date | May 19, 1994 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |