OLYMPUS CK-MB REAGENT— 510(k) K070835

Clearance details

Applicant

Olympus Life & Material Science Europa GmbH (Irish

Product code

Code JHY

Device class

Class 2

Regulation

21 CFR 862.1215

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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