FDA 510(k) Applications for Medical Device Product Code "DKC"
(Alcohol Control Materials)

FDA 510(k) Number Applicant Device Name Decision Date
K934467 BECKMAN-DIAGNOSTIC SYSTEMS GROUP BECKMAN CX AMMONIA/ALCOHOL CONTROL 10/27/1993
K912827 CALA DIAGNOSTICS SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 08/12/1991
K912826 CALA DIAGNOSTICS WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 07/26/1991
K935819 COLUMBIA DIAGNOSTICS, INC. QUALITY CONTROL MATERIAL (ASSAYED) 03/22/1994
K833514 FISHER DIAGNOSTICS TOXI CHEM SERUM ALCOHOL CONTROL 12/08/1983
K031392 MEDICAL ANALYSIS SYSTEMS, INC. MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL 07/01/2003
K843872 SIGMA CHEMICAL CO. ETHANOL CONTROLS LOW & HIGH E5133/E5258 10/31/1984
K933425 SIGMA DIAGNOSTICS, INC. AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 11/16/1993
K932067 SIGMA DIAGNOSTICS, INC. ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III 06/16/1993
K810465 SYVA CO. EMIT-ST ETHYL ALCOHOL SERUM CONTROLS 03/06/1981
K802618 SYVA CO. EMIT-STM ETHYL ALCOHOL URINE CONTROLS 10/31/1980


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