K-number	K060896
Device name	MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
Applicant	Varian, Inc.
Product code	DJC
Device class	Class II
Decision date	Jun 9, 2006
Decision	Substantially Equivalent
Regulation	862.3610

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT

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