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

Name: FDA 510(k) clearance K043202
Creator: U.S. Food and Drug Administration
Published: 2004-12-23

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K043202 for OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279, Substantially Equivalent on 2004-12-23. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2004-11-18
Decision date: 2004-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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