meddevicedb.com FDA Device Reference

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 Class II Traditional
Decision Date
2025-12-30
Sponsor / Applicant
Techno-Path Manufacturing , Ltd.

Technical Specification

510(k) Submission ID K242492
Product Code QCH
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3920
Decision Date 2025-12-30
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) received FDA 510(k) clearance under submission number K242492, sponsored by Techno-Path Manufacturing , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-12-30.

Classification & Regulation

This clearance is catalogued under FDA product code QCH and 21 CFR 866.3920, within the Microbiology review panel as a Class II device.