The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Multifibren U.
| Device ID | K934326 |
| 510k Number | K934326 |
| Device Name: | MULTIFIBREN U |
| Classification | System, Fibrinogen Determination |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-03 |
| Decision Date | 1994-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768017872 | K934326 | 000 |
| 00842768017865 | K934326 | 000 |
| 00842768018503 | K934326 | 000 |
| 00842768018541 | K934326 | 000 |