OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181— 510(k) K080435

Name: FDA 510(k) clearance K080435
Creator: U.S. Food and Drug Administration
Published: 2008-09-05

Substantially Equivalent

Olympus Life Science Research Europa GmbH (Europa)

FDA 510(k) clearance K080435 for OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181, Substantially Equivalent on 2008-09-05. Applicant: Olympus Life Science Research Europa GmbH (Europa). Device class: 2.

Clearance details

Applicant: Olympus Life Science Research Europa GmbH (Europa)
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2008-02-19
Decision date: 2008-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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