AU BICARBONATE REAGENT— 510(k) K131546

Substantially Equivalent

Beckman Coulter Ireland, Inc.

FDA 510(k) clearance K131546 for AU BICARBONATE REAGENT, Substantially Equivalent on 2013-10-09. Applicant: Beckman Coulter Ireland, Inc..

Clearance details

Applicant: Beckman Coulter Ireland, Inc.
Product code: Code KHS
Advisory panel: Clinical Chemistry
Date received: 2013-05-29
Decision date: 2013-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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