Name: Predicase
Price: 199 USD

K-number	K101456
Device name	ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
Applicant	Roche Diagnostics
Product code	JIX
Device class	Class II
Decision date	Sep 8, 2010
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

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