FDA Product Code
FDA Product Code PHJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7280
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132978 | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST | Sequenom, Inc. | 2014-06-13 | Traditional | PDF ↗ |
Product code PHJ · Class II · Hematology. Data: openFDA.