K030012

Substantially Equivalent

CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372

Applicant: Beckman Coulter, Inc.
Product code: JHX
Advisory panel: Clinical Chemistry
Date received: 2003-01-02
Decision date: 2003-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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