Cleared Abbreviated

K132174 - MULTICHEM WBT (FDA 510(k) Clearance)

Class I Toxicology device.

K132174 · Techno-Path Manufacturing , Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
67d
Days
Class 1
Risk

K132174 is an FDA 510(k) clearance for the MULTICHEM WBT. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Techno-Path Manufacturing , Ltd. (Highland Village, US). The FDA issued a Cleared decision on September 20, 2013 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Techno-Path Manufacturing , Ltd. devices

Submission Details

510(k) Number K132174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.