K-number	K914806
Device name	ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
Applicant	Roche Diagnostic Systems, Inc.
Product code	DIF
Device class	Class I
Decision date	Nov 19, 1991
Decision	Substantially Equivalent
Regulation	862.3280

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View the full FDA submission: accessdata.fda.gov

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ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL

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