K-number	K091845
Device name	CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
Applicant	Phadia US, Inc.
Product code	MID
Device class	Class II
Decision date	Jun 7, 2010
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

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