FDA Product Code
FDA Product Code ODV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7750
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071867 | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA | Paragondx, LLC | 2008-04-28 | Traditional | PDF ↗ |
Product code ODV · Class II · Hematology. Data: openFDA.