Name: Predicase
Price: 199 USD

K-number	K093987
Device name	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	DHB
Device class	Class II
Decision date	Mar 28, 2011
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6

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