Prothrombin Fragment 1.2
FDA product code MIF · Class II (moderate risk) · 21 CFR 864.7320 · Hematology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042687 | Enzygnost F+2 (Monoclonal) Test KitMIF · Traditional | Dade Behring, Inc. | 12/10/2004SE |
| K964934 | Thrombonostika F1.2MIF · Traditional | Organon Teknika Corp. | 03/18/1997SE |
| K962176 | TPPMIF · Traditional | Panbio, Inc. | 10/18/1996SE |
| K922934 | Enzygnost F 1+2MIF · Traditional | Behring Diagnostics, Inc. | 11/16/1992SE |
| K920895 | Dade(R) Prothrombin Fragment F1.2 ElisaMIF · Traditional | Baxter Diagnostics, Inc. | 06/04/1992SE |
| K911434 | Thrombonostika F1.2MIF · Traditional | Organon Teknika Corp. | 10/31/1991SE |