K-number	K111369
Device name	THE HELENA V8 IMMUNODISPLACEMENT KIT
Applicant	Helena Laboratories Uk, Ltd.
Product code	CFF
Device class	Class II
Decision date	Jun 26, 2012
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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THE HELENA V8 IMMUNODISPLACEMENT KIT

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