Cleared Traditional

A/C ENZYMATIC HOMOCYSTEINE ASSAY

K030754 · Anticancer, Inc. · Toxicology
Jul 2003
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K030754 is an FDA 510(k) clearance for the A/C 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 July 11, 2003, 123 days after receiving the submission on March 10, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K030754 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2003
Decision Date July 11, 2003
Days to Decision 123 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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