The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Pathromtin.
Device ID | K932011 |
510k Number | K932011 |
Device Name: | PATHROMTIN |
Classification | Activated Partial Thromboplastin |
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 | GFO |
CFR Regulation Number | 864.7925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-23 |
Decision Date | 1993-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PATHROMTIN 81040833 1040833 Dead/Cancelled |
Behringwerke Aktiengesellschaft 0000-00-00 |
PATHROMTIN 79223997 5614094 Live/Registered |
Siemens Healthcare Diagnostics ProductsGmbH 2017-11-08 |
PATHROMTIN 77075350 3494565 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH 2007-01-03 |