K250036
- 510(k) number
- K250036
- Device name
- MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- Applicant
- Beckman Coulter, Inc. CA · US
- Product code
- LTT — Panels, Test, Susceptibility, Antimicrobial
- Decision date
- 2025-08-15
- Date received
- 2025-01-08
- 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: K250036.pdf
Official FDA record: K250036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.