K242492 is an FDA 510(k) clearance for the Multichem ID-G (09339892190). This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3920. Serologic Controls For Microbiology Assays.
| 510(k) Number | K242492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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 |