Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7320](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7320) → MIF — Prothrombin Fragment 1.2

# MIF · Prothrombin Fragment 1.2

_Hematology · 21 CFR 864.7320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF

## Overview

- **Product Code:** MIF
- **Device Name:** Prothrombin Fragment 1.2
- **Regulation:** [21 CFR 864.7320](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7320)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K042687](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF/K042687.md) | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | Dade Behring, Inc. | Dec 10, 2004 | SESE |
| [K964934](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF/K964934.md) | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | Mar 18, 1997 | SESE |
| [K962176](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF/K962176.md) | TPP | Panbio, Inc. | Oct 18, 1996 | SESE |
| [K922934](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF/K922934.md) | ENZYGNOST F 1+2 | Behring Diagnostics, Inc. | Nov 16, 1992 | SESE |
| [K920895](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF/K920895.md) | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | Baxter Diagnostics, Inc. | Jun 4, 1992 | SESE |
| [K911434](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF/K911434.md) | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | Oct 31, 1991 | SESE |

## Top Applicants

- Organon Teknika Corp. — 2 clearances
- Baxter Diagnostics, Inc. — 1 clearance
- Behring Diagnostics, Inc. — 1 clearance
- Dade Behring, Inc. — 1 clearance
- Panbio, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/MIF)

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