Panels › Immunology › Product code PNI · Class 2
Aquaporin-4 Autoantibody
Regulation 866.5665
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Kronus, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 2016 | K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay Kronus, Inc. | PNI |
| Apr 25, 2016 | DEN150030 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay Kronus, Inc. | PNI |
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