FDA Product Code
FDA Product Code MIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7320
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | Dade Behring, Inc. | 2004-12-10 | Traditional | PDF ↗ |
| K964934 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | 1997-03-18 | Traditional | PDF ↗ |
| K962176 | TPP | Panbio, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K922934 | ENZYGNOST F 1+2 | Behring Diagnostics, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K920895 | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | Baxter Diagnostics, Inc. | 1992-06-04 | Traditional | PDF ↗ |
| K911434 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | 1991-10-31 | Traditional | PDF ↗ |
Product code MIF · Class II · Hematology. Data: openFDA.