Cleared Traditional

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

K011692 · Intersect Systems, Inc. · Chemistry
Jul 2001
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K011692 is an FDA 510(k) clearance for the HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on July 25, 2001, 55 days after receiving the submission on May 31, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K011692 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2001
Decision Date July 25, 2001
Days to Decision 55 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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