FDA 510(k) Applications for Medical Device Product Code "KRZ"
(Calibrator For Hemoglobin And Hematocrit Measurement)

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


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