FDA 510(k) Applications for Medical Device Product Code "ORI"
(Levetiracetam Assay)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K232522 | ARK Diagnostics, Inc. | ARK Levetiracetam II Assay | 02/27/2024 |
| K091653 | ARK DIAGNOSTICS,INC | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 | 11/02/2009 |
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