ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)— 510(k) K041866

Name: FDA 510(k) clearance K041866
Creator: U.S. Food and Drug Administration
Published: 2004-09-29

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K041866 for ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA), Substantially Equivalent on 2004-09-29. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 1.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2004-07-09
Decision date: 2004-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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