K-number	K080092
Device name	ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Applicant	Roche Diagnostics Corp.
Product code	JZO
Device class	Class II
Decision date	Jul 28, 2008
Decision	Substantially Equivalent
Regulation	866.5870

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ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

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