Name: Predicase
Price: 199 USD

K-number	K151964
Device name	Xprecia Stride Coagulation System, Xprecia System PT Controls
Applicant	Siemens Healthcare Diagnostics
Product code	GJS
Device class	Class II
Decision date	Sep 30, 2016
Decision	Substantially Equivalent
Regulation	864.7750

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Source

View the full FDA submission: accessdata.fda.gov

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Xprecia Stride Coagulation System, Xprecia System PT Controls

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