510(k) K043202— OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

Substantially Equivalent

Olympus America, Inc.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 2004-11-18
Decision date: 2004-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

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