The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Batroxobin Reagent.
| Device ID | K932787 |
| 510k Number | K932787 |
| Device Name: | BATROXOBIN REAGENT |
| Classification | Bothrops Atrox Reagent |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | Joseph Kiceina |
| Correspondent | Joseph Kiceina BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JCO |
| CFR Regulation Number | 864.8100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768011504 | K932787 | 000 |
| 00842768018725 | K932787 | 000 |