Cleared Traditional

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

K242492 · Techno-Path Manufacturing , Ltd. · Microbiology

Dec 2025

Decision

496d

Days

Class 2

Risk

About This 510(k) Submission

K242492 is an FDA 510(k) clearance for the Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN), a Assayed Quality Control Material For Clinical Microbiology Assays (Class II — Special Controls, product code QCH), submitted by Techno-Path Manufacturing , Ltd. (Co. Tipperary, IE). The FDA issued a Cleared decision on December 30, 2025, 496 days after receiving the submission on August 21, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K242492 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2024
Decision Date	December 30, 2025
Days to Decision	496 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QCH — Assayed Quality Control Material For Clinical Microbiology Assays
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3920
Definition	Serologic Controls For Microbiology Assays