K252114
- 510(k) number
- K252114
- Device name
- MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- Applicant
- Liofilchem s.r.l. IT
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2025-10-02
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252114.pdf
Official FDA record: K252114
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.