FDA Product Code
FDA Product Code OKM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5785
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K081248 | QUANTA LITE OMP PLUS ELISA | Inova Diagnostics, Inc. | 2008-10-27 | Traditional | PDF ↗ |
Product code OKM · Class II · Immunology. Data: openFDA.