The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Thrombinex Bovine Thrombin.
| Device ID | K845000 |
| 510k Number | K845000 |
| Device Name: | THROMBINEX BOVINE THROMBIN |
| Classification | Test, Thrombin Time |
| Applicant | BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Contact | James W Eichelberge |
| Correspondent | James W Eichelberge BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-03-26 |