K-number	K821941
Device name	RHEUMATOID FACTOR REFERENCE PREPARA.
Applicant	Armkel, LLC
Product code	DHR
Device class	Class II
Decision date	Aug 27, 1982
Decision	Substantially Equivalent
Regulation	866.5775

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View the full FDA submission: accessdata.fda.gov

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RHEUMATOID FACTOR REFERENCE PREPARA.

Everything you need for a 510(k) submission. Nothing you don't.