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FDA PMA

ASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGG

Número do PMA: P150045 · 2017-09-19

RequerenteZeus Scientific, Inc.
Data da decisão2017-09-19
Número PMAP150045
Código do produtoMYL
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoMI

Resumo do dispositivo

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2017-09-19. The device is classified under product code MYL. It was reviewed by the MI advisory panel.

Perguntas frequentes

What is the ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Zeus Scientific, Inc..

When did ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG receive FDA 510(k) clearance?

The clearance date for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG can be found in the official FDA records.

Who is the listed applicant for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

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

What is the FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is MYL.

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