Name: Predicase
Price: 199 USD

K-number	K081643
Device name	DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
Applicant	Siemens Healthcare Diagnostics
Product code	MMI
Device class	Class II
Decision date	Jul 3, 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 TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

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