K-number	K001417
Device name	ONTRAK TESTCUP 502, MODEL 3016641
Applicant	Roche Diagnostics Corp.
Product code	DKZ
Device class	Class II
Decision date	Jun 29, 2000
Decision	Substantially Equivalent
Regulation	862.3100

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View the full FDA submission: accessdata.fda.gov

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ONTRAK TESTCUP 502, MODEL 3016641

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