Panels › Immunology › Product code NBS · Class 2
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
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 NBS
| Company | 510(k)s | Recalls |
|---|---|---|
| Inova Diagnostics, Inc. | 2 | 0 |
| Euroimmun US | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 6, 2017 | K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls Inova Diagnostics, Inc. | NBS |
| Sep 11, 2012 | K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) Euroimmun US | NBS |
| Jun 7, 2000 | K000535 | QUANTA LITE LKM-1 ELISA Inova Diagnostics, Inc. | NBS |
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