FDA Product Code QCH: Assayed Quality Control Material For Clinical Microbiology Assays
Serologic Controls For Microbiology Assays
Leading manufacturers include Techno-Path Manufacturing , Ltd..
1
Total
1
Cleared
496d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Assayed Quality Control Material For Clinical Microbiology Assays Devices (Product Code QCH)
1 devices
Cleared
Dec 30, 2025
Multichem ID-G (09339892190)
Techno-Path Manufacturing , Ltd.
Microbiology
496d
About Product Code QCH - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QCH since 2025, with 1 receiving FDA clearance (average review time: 496 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
QCH devices are reviewed by the Microbiology panel. Browse all Microbiology devices →