Cleared Abbreviated

MULTICHEM P

K131992 · Techno-Path Manufacturing , Ltd. · Immunology
Sep 2013
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K131992 is an FDA 510(k) clearance for the MULTICHEM P, 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 25, 2013, 89 days after receiving the submission on June 28, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131992 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date September 25, 2013
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Immunology (IM)
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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