FDA 510(k)

Selux AST System; Model AST Gen 1.0

Número K: K211748 · 2023-04-19

Data da decisão2023-04-19

Código do produtoLON

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Selux AST System; Model AST Gen 1.0 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 2023-04-19 under 510(k) number K211748. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Selux Diagnostics, Inc.. The 510(k) number is K211748.

When did Selux AST System; Model AST Gen 1.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Selux AST System; Model AST Gen 1.0?

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 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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Outros registros que listam Selux Diagnostics, Inc. como candidato(a)

K244044PBC Separator with Selux AST System K223493PBC Separator with Selux AST System K211759Selux AST System; Model AST Gen 1.0

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