K243804
- 510(k) number
- K243804
- Device name
- MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- Applicant
- Beckman Coulter, Inc. CA · US
- Product code
- LTT — Panels, Test, Susceptibility, Antimicrobial
- Decision date
- 2025-08-20
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243804.pdf
Official FDA record: K243804
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.