PhAST instrument and PhAST Blood Culture Gram-negative Panel— 510(k) K253316
Substantially EquivalentPhast Corp.
FDA 510(k) clearance K253316 for PhAST instrument and PhAST Blood Culture Gram-negative Panel, Substantially Equivalent on 2026-06-26. Applicant: Phast Corp.. Device class: 2.
Summary
Phast Corp.'s clearance covers the PhAST instrument and the PhAST Blood Culture Gram-negative Panel. The record lists one product code, SAN, automated antimicrobial susceptibility test systems for positive blood culture samples.
Class II, 21 CFR 866.1650. Microbiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Phast filed from Boston, Massachusetts. The decision came 269 calendar days after FDA received it (September 30, 2025 to June 26, 2026).
Clearance details
- Applicant
- Phast Corp.
- Product code
- Product code SAN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1650
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code SAN
view allData sourced from openFDA. This site is unofficial and independent of the FDA.