The following data is part of a premarket notification filed by Kabivitrum, Inc. with the FDA for Coatest Plasminogen.
| Device ID | K854572 |
| 510k Number | K854572 |
| Device Name: | COATEST PLASMINOGEN |
| Classification | Plasminogen, Antigen, Antiserum, Control |
| Applicant | KABIVITRUM, INC. 1311 HARBOR BAY PKWY. Alameda, CA 94501 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi KABIVITRUM, INC. 1311 HARBOR BAY PKWY. Alameda, CA 94501 |
| Product Code | DDX |
| CFR Regulation Number | 866.5715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-14 |
| Decision Date | 1986-02-26 |