The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade(r) Prothrombin Fragment F1.2 Elisa.
| Device ID | K920895 |
| 510k Number | K920895 |
| Device Name: | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA |
| Classification | Prothrombin Fragment 1.2 |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Alodia M Ruiz |
| Correspondent | Alodia M Ruiz BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | MIF |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-26 |
| Decision Date | 1992-06-04 |