The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Multifibren.
| Device ID | K925988 |
| 510k Number | K925988 |
| Device Name: | MULTIFIBREN |
| Classification | System, Fibrinogen Determination |
| 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 | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-25 |
| Decision Date | 1993-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007170 | K925988 | 000 |
| 00630414640532 | K925988 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MULTIFIBREN 77075239 3497675 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH 2007-01-03 |