FDA Product Code
FDA Product Code GFX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7340
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072304 | FIBRINOGEN CALIBRATOR KIT | Dade Behring, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K994341 | FIBRINOGEN CALIBRATOR KIT | Dade Behring, Inc. | 2000-03-03 | Traditional | PDF ↗ |
| K812628 | ACA FIBRINOGEN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1981-11-24 | Traditional | PDF ↗ |
Product code GFX · Class II · Hematology. Data: openFDA.