Name: Predicase
Price: 199 USD

K-number	K103842
Device name	UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
Applicant	Beckman Coulter, Inc.
Product code	CGA
Device class	Class II
Decision date	Apr 27, 2011
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

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