Name: Predicase
Price: 199 USD

K-number	K181599
Device name	Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
Applicant	Beckman Coulter
Product code	QFS
Device class	Class II
Decision date	Mar 18, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

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