K953393 is an FDA 510(k) clearance for the TOX PERFECT A TUBE. This device is classified as a Digoxin Control Serum, Ria (Class I - General Controls, product code DMP).
Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on October 6, 1995, 84 days after receiving the submission on July 14, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K953393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1995 |
| Decision Date | October 06, 1995 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DMP — Digoxin Control Serum, Ria |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |