ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY— 510(k) K042411

Name: FDA 510(k) clearance K042411
Creator: U.S. Food and Drug Administration
Published: 2005-04-07

Substantially Equivalent

Axis-Shield , Ltd.

FDA 510(k) clearance K042411 for ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY, Substantially Equivalent on 2005-04-07. Applicant: Axis-Shield , Ltd.. Device class: 2.

Clearance details

Applicant: Axis-Shield , Ltd.
Product code: Code NRP
Device class: Class 2
Regulation: 21 CFR 862.3840
Advisory panel: Clinical Toxicology
Date received: 2004-09-07
Decision date: 2005-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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