FDA Product Code
FDA Product Code OBE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific | 2026-05-08 | Traditional | PDF ↗ |
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | Inova Diagnostics, Inc. | 2015-03-05 | Traditional | PDF ↗ |
| K063565 | QUANTA LITE SS-A 52 ELISA | Inova Diagnostics, Inc. | 2007-04-04 | Traditional | PDF ↗ |
Product code OBE · Class II · Immunology. Data: openFDA.