FDA 510(k) Applications for Medical Device Product Code "KRZ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K962864 | ALKO DIAGNOSTIC CORP. | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | 12/18/1996 |
K041130 | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | 06/10/2004 |
K052101 | Roche Diagnostics | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | 08/26/2005 |