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