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 |