FDA Product Code
FDA Product Code OYV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5970
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN190023 | AmplideX Fragile X Dx & Carrier Screen Kit | Asuragen, Inc. | 2020-02-21 | Direct | — |
Product code OYV · Class II · Immunology. Data: openFDA.