K243202
- 510(k) number
- K243202
- Device name
- MTS Ceftobiprole 0.002-32 µg/mL
- Applicant
- Liofilchem s.r.l. IT
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2025-01-30
- Date received
- 2024-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243202
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.