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FDA PMA

System, test, tumor marker, for detection of bladder cancer

Número do PMA: P940035 · 2022-07-12

RequerenteAbbott Diagnostics Scarborough, Inc.
Data da decisão2022-07-12
Número PMAP940035
Código do produtoNAH
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoIM

Resumo do dispositivo

System, test, tumor marker, for detection of bladder cancer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2022-07-12. The device is classified under product code NAH. It was reviewed by the IM advisory panel.

Perguntas frequentes

What is the System, test, tumor marker, for detection of bladder cancer?

System, test, tumor marker, for detection of bladder cancer is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Abbott Diagnostics Scarborough, Inc..

When did System, test, tumor marker, for detection of bladder cancer receive FDA 510(k) clearance?

The clearance date for System, test, tumor marker, for detection of bladder cancer can be found in the official FDA records.

Who is the listed applicant for System, test, tumor marker, for detection of bladder cancer?

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

What is the FDA product code for System, test, tumor marker, for detection of bladder cancer?

The FDA product code for System, test, tumor marker, for detection of bladder cancer is NAH.

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Fonte oficial

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