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FDA 510(k)

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

Número K: K163085 · 2017-02-14

RequerenteFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
Data da decisão2017-02-14
Código do produtoOZN
Comité consultivoMI
DecisãoSubstantially Equivalent

Resumo do dispositivo

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2017-02-14 under 510(k) number K163085. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is a medical device that received FDA 510(k) clearance on 2017-02-14. The listed applicant is Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. The 510(k) number is K163085.

When did Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack receive FDA 510(k) clearance?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack received FDA 510(k) clearance on 2017-02-14, under 510(k) number K163085.

Who is the listed applicant for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

The FDA 510(k) record lists Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

The FDA product code for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is OZN.

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Dispositivos Relacionados (Código: OZN)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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