Name: Predicase
Price: 199 USD

K-number	K081731
Device name	DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
Applicant	Siemens Healthcare Diagnostics
Product code	CGS
Device class	Class II
Decision date	Aug 29, 2008
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

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