K-number	K993360
Device name	PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
Applicant	Roche Diagnostics Corp.
Product code	JJY
Device class	Class I
Decision date	Nov 24, 1999
Decision	Substantially Equivalent
Regulation	862.1660

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PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

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