K-number	K132801
Device name	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	DHB
Device class	Class II
Decision date	May 28, 2014
Decision	Substantially Equivalent
Regulation	866.5750

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View the full FDA submission: accessdata.fda.gov

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IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY

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