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PMA de la FDA

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Número de PMA: P010007 · 2026-09-22

SolicitanteSiemens Healthcare Diagnostics, Inc.
Fecha de decisión2026-09-22
Número PMAP010007
Código de productoLOK
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorIM

Resumen del dispositivo

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-09-22. The device is classified under product code LOK. It was reviewed by the IM advisory panel.

Preguntas frecuentes

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 2026-09-22. The listed applicant is Siemens Healthcare Diagnostics, 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 Siemens Healthcare Diagnostics, 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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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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