PBC Separator with Selux AST System— 510(k) K244044

Name: FDA 510(k) clearance K244044
Creator: U.S. Food and Drug Administration
Published: 2025-03-28

Substantially Equivalent

Selux Diagnostics, Inc.

FDA 510(k) clearance K244044 for PBC Separator with Selux AST System, Substantially Equivalent on 2025-03-28. Applicant: Selux Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Selux Diagnostics, Inc.
Product code: Code QZX
Device class: Class 2
Regulation: 21 CFR 866.1650
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 ↗

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K223493 — PBC Separator with Selux AST System2024-02-15
K231536 — eQUANT System2024-02-08

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