K251580
- 510(k) number
- K251580
- Device name
- MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
- Applicant
- Liofilchem s.r.l. IT
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2025-08-20
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K251580.pdf
Official FDA record: K251580
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.