510(k) K242492
- Device
- 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.
- 510(k) number
- K242492
- Product code
- QCH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-30
- Date received
- 2024-08-21
- Regulation
- 866.3920
- Classification name
- Assayed Quality Control Material For Clinical Microbiology Assays
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alan McDonagh
- Address
- Fort Henry Business Park, Ballina Co. Tipperary IE V94 FF1P V94 FF1P
FDA Registration Numbers#
- 3026565854
- 2024674
- 9610126
- 8023018
- 3002809144
- 2182595
- 3008156187
- 3021090658
- 9680746
- 2431980
- 3033751096
- 3005333358
- 2432235
- 1219913