K-number	K100499
Device name	ORGENTEC RHEUMATOID FACTOR EIA
Applicant	Orgentec Diagnostika GmbH
Product code	DHR
Device class	Class II
Decision date	Oct 27, 2010
Decision	Substantially Equivalent
Regulation	866.5775

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Source

View the full FDA submission: accessdata.fda.gov

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ORGENTEC RHEUMATOID FACTOR EIA

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