Cleared Traditional

TECO HOMOCYSTEINE ENZYMATIC ASSAY

K063701 · Teco Diagnostics · Chemistry
Apr 2007
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K063701 is an FDA 510(k) clearance for the TECO HOMOCYSTEINE ENZYMATIC ASSAY, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on April 11, 2007, 119 days after receiving the submission on December 13, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K063701 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2006
Decision Date April 11, 2007
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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