Name: Predicase
Price: 199 USD

K-number	K151487
Device name	Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
Applicant	Diatron U.S., Inc.
Product code	CFR
Device class	Class II
Decision date	Jan 14, 2016
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

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