K250274
- 510(k) number
- K250274
- Device name
- ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
- Applicant
- Biomerieux S.A. FR
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2025-04-30
- Date received
- 2025-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250274.pdf
Official FDA record: K250274
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.