Name: Predicase
Price: 199 USD

K-number	K080057
Device name	IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
Applicant	Novx Systems, Inc.
Product code	DKZ
Device class	Class II
Decision date	Oct 31, 2008
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

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