Cleared Traditional

HOMOCYSTEINE TEST

K113793 · Roche · Chemistry
Jun 2012
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K113793 is an FDA 510(k) clearance for the HOMOCYSTEINE TEST, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Roche (Indianpolis, US). The FDA issued a Cleared decision on June 5, 2012, 165 days after receiving the submission on December 23, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K113793 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2011
Decision Date June 05, 2012
Days to Decision 165 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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