FDA Product Code
FDA Product Code OPN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090755 | QUANTA LITE APS/PT IGG AND IGM ELISA | Inova Diagnostics, Inc. | 2010-02-01 | Traditional | PDF ↗ |
Product code OPN · Class II · Immunology. Data: openFDA.