FDA 510(k) Applications for Medical Device Product Code "CDM"
(Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.))

FDA 510(k) Number Applicant Device Name Decision Date
K061559 ACON LABORATORIES CO. ACON URINALYSIS REAGENT STRIPS 08/11/2006
K052719 ARJ MEDICAL, INC. URITEST 10 URINALYSIS REAGENT STRIPS 12/05/2006
K830340 BODITESTOR FITKIT I CHECKUP KIT 08/16/1983
K831623 CALIFORNIA IMMUNO DIAGNOSTIC, INC. DIA STRIPS SYSTEM 07/28/1983
K880584 MACH DIAG. C/O WICHITA STATE UNIVERSITY URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C 05/31/1988
K790965 MILES LABORATORIES, INC. REAGENT STRIPS FOR URINALYSIS 06/28/1979
K852611 MILES LABORATORIES, INC. TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE 09/03/1985
K821799 PATTON, BOGGS & BLOW FITKIT I CHECKUP KIT 08/16/1983
K873366 WAKO CHEMICALS, USA, INC. WAKO(TM) PRETEST 5A 01/21/1988


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