QCH — Assayed Quality Control Material For Clinical Microbiology Assays Class II
FDA product code QCH covers "Assayed Quality Control Material For Clinical Microbiology Assays", a Class II medical device regulated under 21 CFR 866.3920. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QCH
- Device Class
- Class II
- Regulation Number
- 866.3920
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Serologic controls for microbiology assays
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242492 | techno-path manufacturing | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); | December 30, 2025 |