Panels › Immunology › Product code OIF · Class 2
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
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 OIF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kronus, Inc. | 2 | 0 |
| Kronus Market Development Associates, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2023 | K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. | OIF |
| Jan 19, 2018 | K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. | OIF |
| Apr 10, 2008 | K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT Kronus Market Development Associates, Inc. | OIF |
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