FDA Product Code
FDA Product Code QKT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.3245
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN190028 | MyCare Psychiatry Clozapine Assay Kit | Saladax Biomedical, Inc. | 2020-04-16 | Direct | — |
Product code QKT · Class II · Clinical Chemistry. Data: openFDA.