K-number	K151321
Device name	D-100 HbA1c, D-100 HbA1c Calibrator Pack
Applicant	Bio-Rad Laboratories, Inc.
Product code	PDJ
Device class	Class II
Decision date	Dec 9, 2015
Decision	Substantially Equivalent
Regulation	862.1373

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View the full FDA submission: accessdata.fda.gov

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D-100 HbA1c, D-100 HbA1c Calibrator Pack

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