K-number	K001356
Device name	ONTRAK TESTCUP PRO-5, MODEL 1986678
Applicant	Roche Diagnostics Corp.
Product code	DJC
Device class	Class II
Decision date	Jul 10, 2000
Decision	Substantially Equivalent
Regulation	862.3610

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View the full FDA submission: accessdata.fda.gov

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ONTRAK TESTCUP PRO-5, MODEL 1986678

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