Name: Predicase
Price: 199 USD

K-number	K061879
Device name	SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
Applicant	Hemodiagnostica, LLC
Product code	CFR
Device class	Class II
Decision date	Dec 15, 2006
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM

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