The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Neothromitin(r).
| Device ID | K924395 |
| 510k Number | K924395 |
| Device Name: | NEOTHROMITIN(R) |
| Classification | Antigen, Cf, Typhus Fever Group |
| 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 | GPO |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1992-12-01 |