K-number	K854129
Device name	ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
Applicant	Orion Diagnostica, Inc.
Product code	LIQ
Device class	Class I
Decision date	Jan 21, 1986
Decision	Substantially Equivalent
Regulation	866.3405

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ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS

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