K-number	K912827
Device name	SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
Applicant	Cala Diagnostics
Product code	DKC
Device class	Class I
Decision date	Aug 12, 1991
Decision	Substantially Equivalent
Regulation	862.3280

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View the full FDA submission: accessdata.fda.gov

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SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3

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