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FDA PMA

ASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGM

Número do PMA: P150042 · 2017-09-19

RequerenteZeus Scientific, Inc.
Data da decisão2017-09-19
Número PMAP150042
Código do produtoMYM
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoMI

Resumo do dispositivo

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM 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 MYM. It was reviewed by the MI advisory panel.

Perguntas frequentes

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

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM 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 IGM receive FDA 510(k) clearance?

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

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

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 IGM?

The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is MYM.

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