FDA 510(k)

Selux AST System; Model AST Gen 1.0

K-Number: K211748 · 2023-04-19

Decision Date2023-04-19

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Selux AST System; Model AST Gen 1.0 is a medical device manufactured by Selux Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-04-19 under approval number K211748. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Selux AST System; Model AST Gen 1.0?

Selux AST System; Model AST Gen 1.0 is a medical device that received FDA 510(k) clearance on 2023-04-19. It is manufactured by Selux Diagnostics, Inc.. The 510(k) number is K211748.

When was Selux AST System; Model AST Gen 1.0 approved by the FDA?

Selux AST System; Model AST Gen 1.0 received FDA 510(k) clearance on 2023-04-19, under approval number K211748.

What company makes Selux AST System; Model AST Gen 1.0?

Selux AST System; Model AST Gen 1.0 is manufactured by Selux Diagnostics, Inc..

What is the FDA product code for Selux AST System; Model AST Gen 1.0?

The FDA product code for Selux AST System; Model AST Gen 1.0 is LON.

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Other Devices by Selux Diagnostics, Inc.

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Official Source

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