Cleared Abbreviated

K131992 - MULTICHEM P (FDA 510(k) Clearance)

Class I Immunology device.

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

K131992 is an FDA 510(k) clearance for the MULTICHEM P. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Techno-Path Manufacturing , Ltd. (Highland Village, US). The FDA issued a Cleared decision on September 25, 2013 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 K131992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 104d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.