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.

FDA 510(k)

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Ensayo, ADVIA Centaur Active-B12(AB12) Control de Calidad y Materiales de Curva Maestra (MCM) de ADVIA Centaur Active-B12 (AB12)

N.º K: K160757 · 2016-07-26

SolicitanteAxis-Shield Diagnostics Limited
Fecha de decisión2016-07-26
Código de productoCDD
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160757. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K160757.

When did ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) receive FDA 510(k) clearance?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160757.

Who is the listed applicant for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

The FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is CDD.

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

Otros registros que enlistan a Axis-Shield Diagnostics Limited como solicitante

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.

K183088ADVIA Centaur Eritropoyetina (EPO) ensayoK182012ADVIA Centaur Calcitonina (CALCT) ensayoK153551Política: regulación medical-vi. Dis El dispositivo_name ADVIA Centaur Anti-CCP IgG (aCCP) assay,., incluyendo reactivos,., calibradores y materiales de controla calidad y curebras.

Dispositivos relacionados (Código: CDD)

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.

K233541ARCHITECT Activo-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) EnsayoAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

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.

↑