K-number	K062319
Device name	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
Applicant	Roche Diagnostics Corp.
Product code	JIX
Device class	Class II
Decision date	Sep 13, 2006
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360

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