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

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