AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON— 510(k) K112790

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K112790 for AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON, Substantially Equivalent on 2012-05-07. Applicant: Axis-Shield Diagnostics, Ltd..

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2011-09-26
Decision date: 2012-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

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