The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Berichrom Alpha-2-antiplasmin.
| Device ID | K884797 |
| 510k Number | K884797 |
| Device Name: | BERICHROM ALPHA-2-ANTIPLASMIN |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-16 |
| Decision Date | 1989-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768011160 | K884797 | 000 |
| 00630414639437 | K884797 | 000 |