FDA 510(k) Applications for Medical Device Product Code "CDL"
(Berthelot Indophenol, Urea Nitrogen)

FDA 510(k) Number Applicant Device Name Decision Date
K761152 ADVANCED BIOMEDICAL METHODS, INC. S-UREA-N, IN VITRO DIAG FOR BUN 12/09/1976
K781306 ANALYTICAL & RESEARCH CHEMICALS, INC. UREA NITROGEN TEST KIT 08/31/1978
K831414 BIO-ANALYTICS LABORATORIES, INC. COLORIMETRIC BUN 06/16/1983
K871651 BIOCHEMICAL TRADE, INC. COLORIMETRIC BUN REAGENT KIT 05/12/1987
K801727 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME UREA NITROGEN, COLORIMETRIC 09/09/1980
K863076 J. D. ASSOC. UREAFAST 09/09/1986
K896845 REAGENTS APPLICATIONS, INC. RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT 02/16/1990
K800902 SCLAVO, INC. BUN-COLOR 2, BLOOD UREA NITROGEN TEST 06/09/1980
K893128 STANBIO LABORATORY STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 07/25/1989
K822237 STERLING BIOCHEMICAL, INC. UREA NITROGEN REAGENT SET (MOD. BERTHEL 08/16/1982
K860154 STERLING DIAGNOSTICS, INC. BUN (ENZYMATIC BERTHELOT) REAGENT SET 02/06/1986
K864742 TECH-CO, INC. UREA NITROGEN(BUN), COLORIMETRIC METHOD 01/13/1987
K863889 U. S. DIAGNOSTICS, INC. UREA NITROGEN TEST 11/24/1986
K792417 VOLU SOL MEDICAL INDUSTRIES ELVI BLOOD UREA NITROGEN 12/07/1979
K810261 VOLU SOL MEDICAL INDUSTRIES EUROCHIMA UREA NITROGEN 02/10/1981
K781899 WAKO INTL., INC. UREA NITROGEN TEST 12/20/1978


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