Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
FDA 510(k) K242492 · Techno-Path Manufacturing , Ltd.
510(k) numberK242492
Submission
- Device name
- Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
- Applicant
- Techno-Path Manufacturing , Ltd.
Co. Tipperary, IE - Received
- August 21, 2024
- Decision date
- December 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QCH – Assayed Quality Control Material For Clinical Microbiology Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3920
- Specialty
- Microbiology
Serologic controls for microbiology assays
More from Techno-Path Manufacturing , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | 03/31/2017SE |
| K132751 | Multichem S Plus / S Plus (Assayed)JJY · Abbreviated | 10/22/2013SE |
| K131993 | Multichem UJJY · Abbreviated | 10/15/2013SE |
| K131992 | Multichem PJJY · Abbreviated | 09/25/2013SE |
| K132174 | Multichem WBTDIF · Abbreviated | 09/20/2013SE |
| K132091 | Multichem Ia and Ia PlusJJY · Abbreviated | 09/20/2013SE |
Questions and answers
When was Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) cleared by the FDA?
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) received a 510(k) decision of Substantially Equivalent on December 30, 2025, 496 days after the submission was received.
What is the product code of K242492?
The FDA product code is QCH – Assayed Quality Control Material For Clinical Microbiology Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.