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FDA PMA

Fluorescence in situ hybridization, chromosome 17p deletion (TP53)

Número do PMA: P150041 · 2026-02-18

RequerenteAbbott Molecular, Inc.
Data da decisão2026-02-18
Número PMAP150041
Código do produtoPNK
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoPA

Resumo do dispositivo

Fluorescence in situ hybridization, chromosome 17p deletion (TP53) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2026-02-18. The device is classified under product code PNK. It was reviewed by the PA advisory panel.

Perguntas frequentes

What is the Fluorescence in situ hybridization, chromosome 17p deletion (TP53)?

Fluorescence in situ hybridization, chromosome 17p deletion (TP53) is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Abbott Molecular, Inc..

When did Fluorescence in situ hybridization, chromosome 17p deletion (TP53) receive FDA 510(k) clearance?

The clearance date for Fluorescence in situ hybridization, chromosome 17p deletion (TP53) can be found in the official FDA records.

Who is the listed applicant for Fluorescence in situ hybridization, chromosome 17p deletion (TP53)?

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

What is the FDA product code for Fluorescence in situ hybridization, chromosome 17p deletion (TP53)?

The FDA product code for Fluorescence in situ hybridization, chromosome 17p deletion (TP53) is PNK.

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Fonte oficial

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