K955115 is an FDA 510(k) clearance for the VENOM TIEM REAGENT. This device is classified as a Bothrops Atrox Reagent (Class II - Special Controls, product code JCO).
Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on April 3, 1996, 146 days after receiving the submission on November 9, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8100.
| 510(k) Number | K955115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1995 |
| Decision Date | April 03, 1996 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JCO — Bothrops Atrox Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8100 |