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 |