OLYMPUS CK-MB REAGENT— 510(k) K070835

Substantially Equivalent

Olympus Life & Material Science Europa GmbH (Irish

FDA 510(k) clearance K070835 for OLYMPUS CK-MB REAGENT, Substantially Equivalent on 2007-06-04. Applicant: Olympus Life & Material Science Europa GmbH (Irish.

Clearance details

Applicant: Olympus Life & Material Science Europa GmbH (Irish
Product code: Code JHY
Advisory panel: Clinical Chemistry
Date received: 2007-03-27
Decision date: 2007-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: O'Callaghans Mills, Co. Clare, IE

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