FDA 510(k) Applications for Medical Device Product Code "CDN"
(Urease, Photometric, Urea Nitrogen)

FDA 510(k) Number Applicant Device Name Decision Date
K113389 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT 08/10/2012
K103615 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD 09/08/2011
K123322 ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT 05/21/2013
K792328 BOEHRINGER MANNHEIM CORP. STATTEK BUN 12/18/1979
K972012 CHOLESTECH CORP. CHOLESTECH BUN/CREATININE TEST SYSTEM 07/24/1997
K781253 COULTER ELECTRONICS, INC. BUN (UREASE) REAGENT 08/21/1978
K914903 EM DIAGNOSTIC SYSTEMS, INC. QUICKSTART UREA NITROGEN 12/31/1991
K132462 HITACHI CHEMICAL DIAGNOSTICS, INC. S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE 10/28/2013
K771442 INSTRUMENTATION LABORATORY CO. MULTISTAT III UREA NITROGEN TEST 08/22/1977
K961196 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) 05/15/1996
K922969 KING DIAGNOSTICS, INC. KING DIAGNOSTICS UREA NITROGEN REAGENT 10/13/1992
K802518 NOBEL SCIENTIFIC INDUSTRIES, INC. BUN REAGENT ASTRA 4 & 8 ANALYZERS 11/12/1980
K001885 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 07/20/2000
K943042 PRISMA SYSTEMS BUN QVET 12/29/1994
K822154 THE DOW CHEMICAL CO. UREA NITROGEN (ENZYMATIC) DETERMINATION 08/05/1982


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