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FDA 510(k)

PBC Separator with Selux AST System

K-Number: K223493 · 2024-02-15

ApplicantSelux Diagnostics, Inc.
Decision Date2024-02-15
Product CodeQZX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PBC Separator with Selux AST System is the device name listed in this FDA 510(k) record. The listed applicant is Selux Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K223493. 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 2024-02-15. The listed applicant is Selux Diagnostics, Inc.. The 510(k) number is K223493.

When did PBC Separator with Selux AST System receive FDA 510(k) clearance?

PBC Separator with Selux AST System received FDA 510(k) clearance on 2024-02-15, under 510(k) number K223493.

Who is the listed applicant for PBC Separator with Selux AST System?

The FDA 510(k) record lists Selux Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Selux Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K244044PBC Separator with Selux AST SystemK211748Selux AST System; Model AST Gen 1.0K211759Selux AST System; Model AST Gen 1.0

Related Devices (Code: QZX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc.K231536eQUANT SystemAvails Medical, Inc.

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.

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