Panels › Hematology › Product code MIF · Class 2
Prothrombin Fragment 1.2
Regulation 864.7320
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MIF
| Company | 510(k)s | Recalls |
|---|---|---|
| Organon Teknika Corp. | 2 | 0 |
| Baxter Diagnostics, Inc. | 1 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Dade Behring, Inc. | 1 | 0 |
| Panbio, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 10, 2004 | K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT Dade Behring, Inc. | MIF |
| Mar 18, 1997 | K964934 | THROMBONOSTIKA F1.2 Organon Teknika Corp. | MIF |
| Oct 18, 1996 | K962176 | TPP Panbio, Inc. | MIF |
| Nov 16, 1992 | K922934 | ENZYGNOST F 1+2 Behring Diagnostics, Inc. | MIF |
| Jun 4, 1992 | K920895 | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA Baxter Diagnostics, Inc. | MIF |
| Oct 31, 1991 | K911434 | THROMBONOSTIKA F1.2 Organon Teknika Corp. | MIF |
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