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FDA PMA

Nucleic Acid Based Assay, Microsatellite Instability

Número do PMA: P250046 · 2026-09-15

RequerentePromega Corporation
Data da decisão2026-09-15
Número PMAP250046
Código do produtoSFL
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoMG

Resumo do dispositivo

Nucleic Acid Based Assay, Microsatellite Instability is the device name listed in this FDA 510(k) record. The listed applicant is Promega Corporation. It received FDA 510(k) clearance on 2026-09-15. The device is classified under product code SFL. It was reviewed by the MG advisory panel.

Perguntas frequentes

What is the Nucleic Acid Based Assay, Microsatellite Instability?

Nucleic Acid Based Assay, Microsatellite Instability is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Promega Corporation.

When did Nucleic Acid Based Assay, Microsatellite Instability receive FDA 510(k) clearance?

The clearance date for Nucleic Acid Based Assay, Microsatellite Instability can be found in the official FDA records.

Who is the listed applicant for Nucleic Acid Based Assay, Microsatellite Instability?

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

What is the FDA product code for Nucleic Acid Based Assay, Microsatellite Instability?

The FDA product code for Nucleic Acid Based Assay, Microsatellite Instability is SFL.

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