The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Berichrom Heparin.
| Device ID | K925200 |
| 510k Number | K925200 |
| Device Name: | BERICHROM HEPARIN |
| Classification | Assay, Heparin |
| 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 | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1993-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012945 | K925200 | 000 |