The following data is part of a premarket notification filed by Kabivitrum, Inc. with the FDA for Coatest Antiplasmin.
| Device ID | K833890 |
| 510k Number | K833890 |
| Device Name: | COATEST ANTIPLASMIN |
| Classification | Assay, Alpha-2-antiplasmin |
| Applicant | KABIVITRUM, INC. CA |
| Product Code | LGP |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-09 |
| Decision Date | 1984-01-30 |