K-number	K052101
Device name	C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
Applicant	Roche Diagnostics
Product code	KRZ
Device class	Class II
Decision date	Aug 26, 2005
Decision	Substantially Equivalent
Regulation	864.8165

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View the full FDA submission: accessdata.fda.gov

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C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C

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