Name: Predicase
Price: 199 USD

K-number	K053577
Device name	DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
Applicant	Dade Behring, Inc.
Product code	MMI
Device class	Class II
Decision date	Apr 14, 2006
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

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