Name: Predicase
Price: 199 USD

K-number	K100433
Device name	IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
Applicant	Siemens Healthcare Diagnostics
Product code	LKQ
Device class	Class II
Decision date	May 13, 2010
Decision	Substantially Equivalent
Regulation	866.3175

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

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