FDA Product Code
FDA Product Code NIY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | Euroimmun US | 2013-04-12 | Traditional | PDF ↗ |
| K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | Euroimmun US | 2012-09-11 | Traditional | PDF ↗ |
| K021482 | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA | Inova Diagnostics, Inc. | 2002-07-30 | Traditional | PDF ↗ |
Product code NIY · Class II · Immunology. Data: openFDA.