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) clearance K242492 · decided 2025-12-30
Clearance details
- K-number
- K242492
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-21
- Decision date
- 2025-12-30
- Days to decision
- 496 days
- Clearance type
- Traditional
- Product code
- QCH
- Device class
- 2
- Regulation number
- 866.3920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Co. Tipperary, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.