Name: Predicase
Price: 199 USD

K-number	K142985
Device name	UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
Applicant	Beckman Coulter, Inc.
Product code	JIT
Device class	Class II
Decision date	Feb 26, 2015
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator

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