Name: Predicase
Price: 199 USD

K-number	K151259
Device name	Sysmex Automated Blood Coagulation Analyzer CS-2100i
Applicant	Siemens Healthcare Diagnostics Products GmbH
Product code	JPA
Device class	Class II
Decision date	Jan 26, 2016
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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Sysmex Automated Blood Coagulation Analyzer CS-2100i

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