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.. Device class: 2.

Clearance details

Applicant: Beckman Coulter Ireland, Inc.
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
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

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.