The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Bc Thrombin Reagent.
| Device ID | K970645 |
| 510k Number | K970645 |
| Device Name: | BC THROMBIN REAGENT |
| Classification | Test, Thrombin Time |
| Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers, Jr. |
| Correspondent | Paul L Rogers, Jr. BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013102 | K970645 | 000 |