OLYMPUS CREATINE KINASE REAGENT OSR6179/6279— 510(k) K994189

Name: FDA 510(k) clearance K994189
Creator: U.S. Food and Drug Administration
Published: 2000-01-20

Substantially Equivalent

Olympus Diagnostica GmbH

FDA 510(k) clearance K994189 for OLYMPUS CREATINE KINASE REAGENT OSR6179/6279, Substantially Equivalent on 2000-01-20. Applicant: Olympus Diagnostica GmbH. Device class: 2.

Clearance details

Applicant: Olympus Diagnostica GmbH
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1999-12-13
Decision date: 2000-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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