HbA1c Advanced— 510(k) K182651

Substantially Equivalent

Beckman Coulter Ireland, Inc.

FDA 510(k) clearance K182651 for HbA1c Advanced, Substantially Equivalent on 2019-01-16. Applicant: Beckman Coulter Ireland, Inc..

Clearance details

Applicant: Beckman Coulter Ireland, Inc.
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2018-09-24
Decision date: 2019-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: O'Callaghan'S Mills, IE

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