Panels › Immunology › Product code NIY · Class 2
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Regulation 866.5660
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NIY
| Company | 510(k)s | Recalls |
|---|---|---|
| Euroimmun US | 2 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2013 | K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) Euroimmun US | NIY |
| Sep 11, 2012 | K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) Euroimmun US | NIY |
| Jul 30, 2002 | K021482 | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA Inova Diagnostics, Inc. | NIY |
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