FDA 510(k) Applications for Medical Device Product Code "CDS"
(Electrode, Ion Specific, Urea Nitrogen)

FDA 510(k) Number Applicant Device Name Decision Date
K761061 BECKMAN INSTRUMENTS, INC. BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 01/25/1977
K760430 BOEHRINGER MANNHEIM CORP. BUN-REATIVE 11/01/1976
K811193 CHEM-ELEC, INC. BUN RATE REAGENT 07/10/1981
K033056 DIAMOND DIAGNOSTICS, INC. BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT 01/30/2004
K791018 FERMCO BIOCHEMICS, INC. FERMCOTEST R BUN RATE REAGENT TEST KIT 07/17/1979
K800071 FISHER SCIENTIFIC CO., LLC. BUN REAGENT KIT 02/05/1980
K040973 GENCHEM, INC. BUN REAGENT 12/27/2004
K800616 HI CHEM, INC. BUN REAGENT KIT #88108 04/10/1980
K925550 HICHEM DIAGNOSTICS HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 04/20/1993
K860543 ILEX CORP. BLOOD UREA NITROGEN (BUN) TESTCARD 04/21/1986
K771060 J.T. BAKER CHEMICAL CO. DIAG. CONDUCTA RATE BUN REAG. SET 07/21/1977
K800590 NOBEL SCIENTIFIC INDUSTRIES, INC. BUN KIT 04/04/1980
K855091 SENTECH MEDICAL CORP. CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS 03/14/1986
K812308 SHERWOOD MEDICAL CO. LANCER BUN RATE REAGENT KIT 08/31/1981


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