K-number	K994030
Device name	ONTRAK TESTCUP 5, CAT. 07 6481 7
Applicant	Roche Diagnostics Corp.
Product code	LCM
Device class	Class U
Decision date	Jan 27, 2000
Decision	Substantially Equivalent
Regulation	—

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ONTRAK TESTCUP 5, CAT. 07 6481 7

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