K142448

Substantially Equivalent

VARIANT II TURBO HbA1c Kit - 2.0

Applicant: Bio-Rad Laboratories, Inc.
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2014-09-02
Decision date: 2015-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

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