K-number	K983694
Device name	ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
Applicant	The Binding Site, Ltd.
Product code	MID
Device class	Class II
Decision date	Feb 5, 1999
Decision	Substantially Equivalent
Regulation	866.5660

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View the full FDA submission: accessdata.fda.gov

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ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT

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