The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Turbiquant.
Device ID | K920124 |
510k Number | K920124 |
Device Name: | TURBIQUANT |
Classification | System, Test, Rheumatoid Factor |
Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Contact | Hughes |
Correspondent | Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-10 |
Decision Date | 1992-03-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TURBIQUANT 73709315 1581006 Dead/Cancelled |
BEHRINGWERKE AKTIENGESELLSCHAFT 1988-02-04 |