The following data is part of a premarket notification filed by Kabivitrum, Inc. with the FDA for Coatest Protein C.
| Device ID | K884058 |
| 510k Number | K884058 |
| Device Name: | COATEST PROTEIN C |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | KABIVITRUM, INC. 1311 HARBOR BAY PKWY. Alameda, CA 94501 |
| Contact | G Leonardi |
| Correspondent | G Leonardi KABIVITRUM, INC. 1311 HARBOR BAY PKWY. Alameda, CA 94501 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1988-12-13 |