K-number	K851099
Device name	IGM RHEUMATOID FACTOR TEST KIT
Applicant	Breit Laboratories, Inc.
Product code	DHR
Device class	Class II
Decision date	Apr 25, 1985
Decision	Substantially Equivalent
Regulation	866.5775

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View the full FDA submission: accessdata.fda.gov

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IGM RHEUMATOID FACTOR TEST KIT

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