K935081 is an FDA 510(k) clearance for the DIRECTDRAW SUPERSERUM-MINI. 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 January 11, 1994, 78 days after receiving the submission on October 25, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K935081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1993 |
| Decision Date | January 11, 1994 |
| Days to Decision | 78 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 |