FDA 510(k)

Lucica Glycated Albumin-L

N.º K: K170147 · 2017-10-12

SolicitanteAsahi Kasei Pharma Corporation

Fecha de decisión2017-10-12

Código de productoLCP

Comité asesorHE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lucica Glycated Albumin-L is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Pharma Corporation. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170147. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Lucica Glycated Albumin-L?

Lucica Glycated Albumin-L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Asahi Kasei Pharma Corporation. The 510(k) number is K170147.

When did Lucica Glycated Albumin-L receive FDA 510(k) clearance?

Lucica Glycated Albumin-L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170147.

Who is the listed applicant for Lucica Glycated Albumin-L?

The FDA 510(k) record lists Asahi Kasei Pharma Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucica Glycated Albumin-L?

The FDA product code for Lucica Glycated Albumin-L is LCP.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: LCP)

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation K231465Q-Pad Test SystemQurasense K214117Afinion™ HbA1c, Afinion™ 2 y Alere Afinion™ AS100 AnalizadorAbbott Diagnostics Technologies AS K192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

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.