K151321

Substantially Equivalent

D-100 HbA1c, D-100 HbA1c Calibrator Pack

Applicant: Bio-Rad Laboratories, Inc.
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2015-05-18
Decision date: 2015-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

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