FDA 510(k) Applications for Medical Device Product Code "OIF"
(Tyrosine Phosphatase (Ia-2) Autoantibody Assay)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K073590 | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | 04/10/2008 |
| K171731 | Kronus, Inc. | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | 01/19/2018 |
| K220085 | KRONUS, Inc. | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | 08/24/2023 |
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