510(k) K242492
K242492 is an FDA 510(k) premarket notification submitted by Techno-Path Manufacturing , Ltd. for the device "Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)". The FDA issued a decision of Substantially Equivalent on December 30, 2025. The device falls under product code QCH (Assayed Quality Control Material For Clinical Microbiology Assays), a Class II device regulated under 21 CFR 866.3920. Techno-Path Manufacturing , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2025
- Date Received
- August 21, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assayed Quality Control Material For Clinical Microbiology Assays
- Device Class
- Class II
- Regulation Number
- 866.3920
- Review Panel
- MI
- Submission Type
Serologic controls for microbiology assays