K253316
- 510(k) number
- K253316
- Device name
- PhAST instrument and PhAST Blood Culture Gram-negative Panel
- Applicant
- Phast Corp. MA · US
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2026-06-26
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K253316.pdf
Official FDA record: K253316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.