FDA 510(k) Applications for Medical Device Product Code "OIF"
|
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 |