Cleared Traditional

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

K073640 · Axis-Shield Diagnostics, Ltd. · Chemistry
Apr 2008
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K073640 is an FDA 510(k) clearance for the ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on April 24, 2008, 120 days after receiving the submission on December 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K073640 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2007
Decision Date April 24, 2008
Days to Decision 120 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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