AXSYM CORTISOL ASSAY— 510(k) K033731

Name: FDA 510(k) clearance K033731
Creator: U.S. Food and Drug Administration
Published: 2004-02-20

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K033731 for AXSYM CORTISOL ASSAY, Substantially Equivalent on 2004-02-20. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code JFT
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2003-11-28
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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