FDA Product Code
FDA Product Code QDH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1093
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN180004 | picoAMH ELISA | Ansh Labs, LLC | 2018-10-24 | Direct | — |
Product code QDH · Class II · Clinical Chemistry. Data: openFDA.