K140654

Substantially Equivalent

Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

Applicant: Abbott Laboratories
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2014-03-14
Decision date: 2015-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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