K-number	K111919
Device name	IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
Applicant	Phadia US, Inc.
Product code	DHB
Device class	Class II
Decision date	Dec 22, 2011
Decision	Substantially Equivalent
Regulation	866.5750

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View the full FDA submission: accessdata.fda.gov

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IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

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