K-number	K990399
Device name	ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
Applicant	Roche Diagnostics Corp.
Product code	DKZ
Device class	Class II
Decision date	Apr 15, 1999
Decision	Substantially Equivalent
Regulation	862.3100

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View the full FDA submission: accessdata.fda.gov

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ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8

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