Cleared Abbreviated

MULTICHEM IA AND IA PLUS

K132091 · Techno-Path Manufacturing , Ltd. · Chemistry
Sep 2013
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K132091 is an FDA 510(k) clearance for the MULTICHEM IA AND IA PLUS, 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 September 20, 2013, 74 days after receiving the submission on July 8, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K132091 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2013
Decision Date September 20, 2013
Days to Decision 74 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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