K-number	K132978
Device name	IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
Applicant	Sequenom, Inc.
Product code	PHJ
Device class	Class II
Decision date	Jun 13, 2014
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST

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