K-number	K083314
Device name	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Applicant	Siemens Healthcare Diagnostics
Product code	DHB
Device class	Class II
Decision date	Mar 11, 2009
Decision	Substantially Equivalent
Regulation	866.5750

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View the full FDA submission: accessdata.fda.gov

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IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

Everything you need for a 510(k) submission. Nothing you don't.