The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost F 1+2.
| Device ID | K922934 |
| 510k Number | K922934 |
| Device Name: | ENZYGNOST F 1+2 |
| Classification | Prothrombin Fragment 1.2 |
| 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 | MIF |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1992-11-16 |