510(k) K132571— ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY

Substantially Equivalent

Roche Diagnostics

Clearance details

Applicant: Roche Diagnostics
Product code: Code JHY
Advisory panel: Clinical Chemistry
Date received: 2013-08-15
Decision date: 2013-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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