Cleared Traditional

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

K112790 · Axis-Shield Diagnostics, Ltd. · Chemistry
May 2012
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K112790 is an FDA 510(k) clearance for the AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on May 7, 2012, 224 days after receiving the submission on September 26, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K112790 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2011
Decision Date May 07, 2012
Days to Decision 224 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LPS — Urinary Homocystine (nonquantitative) Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1377

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