Cleared Abbreviated

MULTICHEM WBT

K132174 · Techno-Path Manufacturing , Ltd. · Toxicology
Sep 2013
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K132174 is an FDA 510(k) clearance for the MULTICHEM WBT, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Techno-Path Manufacturing , Ltd. (Highland Village, US). The FDA issued a Cleared decision on September 20, 2013, 67 days after receiving the submission on July 15, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K132174 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2013
Decision Date September 20, 2013
Days to Decision 67 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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