K-number	K841319
Device name	ROTALEX LATEX AGGLUTINATION TEST
Applicant	Orion Diagnostica, Inc.
Product code	LIQ
Device class	Class I
Decision date	Sep 14, 1984
Decision	Substantially Equivalent
Regulation	866.3405

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View the full FDA submission: accessdata.fda.gov

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ROTALEX LATEX AGGLUTINATION TEST

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