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FDA 510(k)

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

Número K: K200506 · 2020-06-03

RequerenteChembio Diagnostic Systems
Data da decisão2020-06-03
Código do produtoQFO
Comité consultivoMI
DecisãoSubstantially Equivalent

Resumo do dispositivo

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is the device name listed in this FDA 510(k) record. The listed applicant is Chembio Diagnostic Systems. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200506. The device is classified under product code QFO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Chembio Diagnostic Systems. The 510(k) number is K200506.

When did DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader receive FDA 510(k) clearance?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200506.

Who is the listed applicant for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

The FDA 510(k) record lists Chembio Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

The FDA product code for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is QFO.

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Dispositivos Relacionados (Código: QFO)

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