MIF — Prothrombin Fragment 1.2 Class II
FDA product code MIF covers "Prothrombin Fragment 1.2", a Class II medical device regulated under 21 CFR 864.7320. Submissions are reviewed by the Hematology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MIF
- Device Class
- Class II
- Regulation Number
- 864.7320
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042687 | dade behring | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | December 10, 2004 |
| K964934 | organon teknika | THROMBONOSTIKA F1.2 | March 18, 1997 |
| K962176 | panbio | TPP | October 18, 1996 |
| K922934 | behring diagnostics | ENZYGNOST F 1+2 | November 16, 1992 |
| K920895 | baxter diagnostics | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | June 4, 1992 |
| K911434 | organon teknika | THROMBONOSTIKA F1.2 | October 31, 1991 |