FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
K Number: K242492
·
Decision Dec 30, 2025
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
0
Applicant Total
6
Review Days
496
Basic Information
- 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)
- K Number
- K242492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3920
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techno-Path Manufacturing , Ltd.
- Date Received
- August 21, 2024
- Decision Date
- December 30, 2025
- Product Code
- QCH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | FDA class 2 | Microbiology |
Other Clearances by Techno-Path Manufacturing , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K132751 | MULTICHEM S PLUS / S PLUS (ASSAYED) | Oct 22, 2013 | Substantially Equivalent |
| K131993 | MULTICHEM U | Oct 15, 2013 | Substantially Equivalent |
| K131992 | MULTICHEM P | Sep 25, 2013 | Substantially Equivalent |
| K132174 | MULTICHEM WBT | Sep 20, 2013 | Substantially Equivalent |
| K132091 | MULTICHEM IA AND IA PLUS | Sep 20, 2013 | Substantially Equivalent |