K932787 is an FDA 510(k) clearance for the BATROXOBIN REAGENT. This device is classified as a Bothrops Atrox Reagent (Class II - Special Controls, product code JCO).
Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on November 29, 1993, 173 days after receiving the submission on June 9, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8100.
| 510(k) Number | K932787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1993 |
| Decision Date | November 29, 1993 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JCO — Bothrops Atrox Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8100 |