PBC Separator with Selux AST System
K-Number: K244044 · 2025-03-28
ApplicantSelux Diagnostics, Inc.
Decision Date2025-03-28
Product CodeQZX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
PBC Separator with Selux AST System is a medical device manufactured by Selux Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-03-28 under approval number K244044. The device is classified under product code QZX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PBC Separator with Selux AST System?
PBC Separator with Selux AST System is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Selux Diagnostics, Inc.. The 510(k) number is K244044.
When was PBC Separator with Selux AST System approved by the FDA?
PBC Separator with Selux AST System received FDA 510(k) clearance on 2025-03-28, under approval number K244044.
What company makes PBC Separator with Selux AST System?
PBC Separator with Selux AST System is manufactured by Selux Diagnostics, Inc..
What is the FDA product code for PBC Separator with Selux AST System?
The FDA product code for PBC Separator with Selux AST System is QZX.
Other Devices by Selux Diagnostics, Inc.
Related Devices (Code: QZX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.