K-number	K912755
Device name	ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
Applicant	Roche Diagnostic Systems, Inc.
Product code	DJP
Device class	Class II
Decision date	Aug 26, 1991
Decision	Substantially Equivalent
Regulation	862.3100

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View the full FDA submission: accessdata.fda.gov

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ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE

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