The following data is part of a premarket notification filed by Kabivitrum, Inc. with the FDA for Coatest Antithrombin.
| Device ID | K812829 |
| 510k Number | K812829 |
| Device Name: | COATEST ANTITHROMBIN |
| Classification | Antithrombin Iii Quantitation |
| Applicant | KABIVITRUM, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-08 |
| Decision Date | 1981-12-30 |