Cleared Abbreviated

MULTICHEM U

K131993 · Techno-Path Manufacturing , Ltd. · Chemistry
Oct 2013
Decision
109d
Days
Class 1
Risk

About This 510(k) Submission

K131993 is an FDA 510(k) clearance for the MULTICHEM U, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Techno-Path Manufacturing , Ltd. (Highland Village, US). The FDA issued a Cleared decision on October 15, 2013, 109 days after receiving the submission on June 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131993 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date October 15, 2013
Days to Decision 109 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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