The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Pathromtin Sl.
| Device ID | K955450 |
| 510k Number | K955450 |
| Device Name: | PATHROMTIN SL |
| Classification | Activated Partial Thromboplastin |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy M Johansen |
| Correspondent | Nancy M Johansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-29 |
| Decision Date | 1996-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007538 | K955450 | 000 |
| 00842768007521 | K955450 | 000 |
| 00842768019074 | K955450 | 000 |