MIF · Prothrombin Fragment 1.2
Hematology · 21 CFR 864.7320 · Class 2
Overview
| Product Code | MIF |
|---|---|
| Device Name | Prothrombin Fragment 1.2 |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | Dade Behring, Inc. | Dec 10, 2004 | SESE |
| K964934 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | Mar 18, 1997 | SESE |
| K962176 | TPP | Panbio, Inc. | Oct 18, 1996 | SESE |
| K922934 | ENZYGNOST F 1+2 | Behring Diagnostics, Inc. | Nov 16, 1992 | SESE |
| K920895 | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | Baxter Diagnostics, Inc. | Jun 4, 1992 | SESE |
| K911434 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | Oct 31, 1991 | SESE |
Top Applicants
- Organon Teknika Corp. — 2 clearances
- Panbio, Inc. — 1 clearance
- Dade Behring, Inc. — 1 clearance
- Behring Diagnostics, Inc. — 1 clearance
- Baxter Diagnostics, Inc. — 1 clearance
