Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

PMA de la FDA

Immunohistochemistry assay, antibody, Ki-67

Número de PMA: P210026 · 2026-09-11

SolicitanteAgilent Technologies, Inc.
Fecha de decisión2026-09-11
Número PMAP210026
Código de productoQQT
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorPA

Resumen del dispositivo

Immunohistochemistry assay, antibody, Ki-67 is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2026-09-11. The device is classified under product code QQT. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the Immunohistochemistry assay, antibody, Ki-67?

Immunohistochemistry assay, antibody, Ki-67 is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Agilent Technologies, Inc..

When did Immunohistochemistry assay, antibody, Ki-67 receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, Ki-67 can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, Ki-67?

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

What is the FDA product code for Immunohistochemistry assay, antibody, Ki-67?

The FDA product code for Immunohistochemistry assay, antibody, Ki-67 is QQT.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑