Cleared Traditional

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY

K080851 · Anticancer, Inc. · Chemistry
Oct 2008
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K080851 is an FDA 510(k) clearance for the A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Anticancer, Inc. (San Diego, US). The FDA issued a Cleared decision on October 10, 2008, 198 days after receiving the submission on March 26, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K080851 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2008
Decision Date October 10, 2008
Days to Decision 198 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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