PhAST instrument and PhAST Blood Culture Gram-negative Panel— 510(k) K253316

Name: FDA 510(k) clearance K253316
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Substantially Equivalent

Phast 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.

Clearance details

Applicant: Phast Corp.
Product code: Code SAN
Device class: Class 2
Regulation: 21 CFR 866.1650
Advisory panel: Microbiology
Date received: 2025-09-30
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.