PBC Separator with Selux AST System— 510(k) K223493

Substantially Equivalent

Selux Diagnostics, Inc.

FDA 510(k) clearance K223493 for PBC Separator with Selux AST System, Substantially Equivalent on 2024-02-15. Applicant: Selux Diagnostics, Inc..

Clearance details

Applicant
Selux Diagnostics, Inc.
Product code
Code QZX
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Charlestown, MA, US
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