K-number	K102673
Device name	RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Applicant	Phadia US, Inc.
Product code	DHR
Device class	Class II
Decision date	Sep 30, 2011
Decision	Substantially Equivalent
Regulation	866.5775

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Source

View the full FDA submission: accessdata.fda.gov

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RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

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