Cleared Traditional

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

K083222 · Axis-Shield Diagnostics, Ltd. · Chemistry
Jul 2009
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K083222 is an FDA 510(k) clearance for the AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100, 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 July 31, 2009, 270 days after receiving the submission on November 3, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K083222 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2008
Decision Date July 31, 2009
Days to Decision 270 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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