K243499
- 510(k) number
- K243499
- Device name
- NG-Test® CTX-M MULTI
- Applicant
- Ng Biotech FR
- Product code
- PTJ — Phenotypic Test Kit, Non-Susceptible/Elevated Mic Or
- Decision date
- 2025-06-04
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243499.pdf
Official FDA record: K243499
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.