K-number	K093421
Device name	ELECSYS TESTOSTERONE II IMMUNOASSAY
Applicant	Roche Diagnostics Corp.
Product code	CDZ
Device class	Class I
Decision date	Apr 23, 2010
Decision	Substantially Equivalent
Regulation	862.1680

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View the full FDA submission: accessdata.fda.gov

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ELECSYS TESTOSTERONE II IMMUNOASSAY

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