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CDM — Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Class I

FDA Device Classification

Classification Details

Product Code
CDM
Device Class
Class I
Regulation Number
862.1785
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052719arj medicalURITEST 10 URINALYSIS REAGENT STRIPSDecember 5, 2006
K061559acon laboratoriesACON URINALYSIS REAGENT STRIPSAugust 11, 2006
K880584mach diag. c/o wichita state universityURI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMay 31, 1988
K873366wako chemicals usaWAKO(TM) PRETEST 5AJanuary 21, 1988
K852611miles laboratoriesTEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINESeptember 3, 1985
K821799patton, boggs and blowFITKIT I CHECKUP KITAugust 16, 1983
K830340boditestorFITKIT I CHECKUP KITAugust 16, 1983
K831623california immuno diagnosticDIA STRIPS SYSTEMJuly 28, 1983
K790965miles laboratoriesREAGENT STRIPS FOR URINALYSISJune 28, 1979