K250084
- 510(k) number
- K250084
- Device name
- MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- Applicant
- Beckman Coulter, Inc. CA · US
- Product code
- LTT — Panels, Test, Susceptibility, Antimicrobial
- Decision date
- 2025-07-18
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K250084.pdf
Official FDA record: K250084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.