FDA product code MIF: Prothrombin Fragment 1.2
MIF is the FDA product code for prothrombin fragment 1.2. It is a Class II device, regulated under 21 CFR 864.7320 and reviewed by the Hematology panel. FDA has cleared 6 510(k) submissions under MIF, from 5 different applicants. The average 510(k) review took 128 days (median 117).
Classification
| Field | Value |
|---|---|
| Device name | Prothrombin Fragment 1.2 |
| Device class | Class II |
| Regulation | 21 CFR 864.7320 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MIF clearance
Top MIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon Teknika Corp. | 2 | 1997-03-18 |
| Dade Behring, Inc. | 1 | 2004-12-10 |
| Panbio, Inc. | 1 | 1996-10-18 |
| Behring Diagnostics, Inc. | 1 | 1992-11-16 |
| Baxter Diagnostics, Inc. | 1 | 1992-06-04 |
Most recent MIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042687 | Dade Behring, Inc. | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | 2004-12-10 | 72 |
| K964934 | Organon Teknika Corp. | THROMBONOSTIKA F1.2 | 1997-03-18 | 99 |
| K962176 | Panbio, Inc. | TPP | 1996-10-18 | 135 |
| K922934 | Behring Diagnostics, Inc. | ENZYGNOST F 1+2 | 1992-11-16 | 151 |
| K920895 | Baxter Diagnostics, Inc. | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | 1992-06-04 | 99 |
Recalls for MIF devices
openFDA lists no recalls for product code MIF.
Frequently asked questions
What is FDA product code MIF?
MIF is the FDA product code for prothrombin fragment 1.2. It is a Class II device, regulated under 21 CFR 864.7320 and reviewed by the Hematology panel.
What device class is MIF?
Class II, regulation 21 CFR 864.7320. Typical premarket route: 510(k).
How long does a 510(k) take for product code MIF?
Across 6 cleared submissions the average was 128 days from receipt to decision (median 117).
Which companies have the most MIF clearances?
Organon Teknika Corp. (2); Dade Behring, Inc. (1); Panbio, Inc. (1); Behring Diagnostics, Inc. (1); Baxter Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MIF
- Run a recall and safety report across every MIF manufacturer
- Watch product code MIF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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