K244044

Substantially Equivalent

PBC Separator with Selux AST System

Applicant: Selux Diagnostics, Inc.
Product code: QZX
Advisory panel: Microbiology
Date received: 2024-12-30
Decision date: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlestown, MA, US

Download summary PDF View on FDA.gov ↗

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