FDA 510(k) Applications for Medical Device Product Code "NIY"
(Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K112221 | EUROIMMUN US | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | 09/11/2012 |
| K113439 | EUROIMMUN US | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | 04/12/2013 |
| K021482 | INOVA DIAGNOSTICS, INC. | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA | 07/30/2002 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
