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FDA PMA

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Número do PMA: P970037 · 2021-08-11

RequerenteRevvity, Inc.
Data da decisão2021-08-11
Número PMAP970037
Código do produtoLOK
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoIM

Resumo do dispositivo

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is the device name listed in this FDA 510(k) record. The listed applicant is Revvity, Inc.. It received FDA 510(k) clearance on 2021-08-11. The device is classified under product code LOK. It was reviewed by the IM advisory panel.

Perguntas frequentes

What is the KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Revvity, Inc..

When did KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS receive FDA 510(k) clearance?

The clearance date for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS can be found in the official FDA records.

Who is the listed applicant for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

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

What is the FDA product code for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

The FDA product code for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is LOK.

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