K-number	K983387
Device name	ONTRAK TESTCUP AND TESTSTIK CONTROLS
Applicant	Roche Diagnostic Systems, Inc.
Product code	DIF
Device class	Class I
Decision date	Oct 9, 1998
Decision	Substantially Equivalent
Regulation	862.3280

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View the full FDA submission: accessdata.fda.gov

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ONTRAK TESTCUP AND TESTSTIK CONTROLS

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