FDA 510(k)

BC-5390 Auto Hematology Analyzer

Número K: K160429 · 2016-09-01

RequerenteMindray Bio-Medical Electronics Co., Ltd.

Data da decisão2016-09-01

Código do produtoGKZ

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BC-5390 Auto Hematology Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K160429. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BC-5390 Auto Hematology Analyzer?

BC-5390 Auto Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K160429.

When did BC-5390 Auto Hematology Analyzer receive FDA 510(k) clearance?

BC-5390 Auto Hematology Analyzer received FDA 510(k) clearance on 2016-09-01, under 510(k) number K160429.

Who is the listed applicant for BC-5390 Auto Hematology Analyzer?

The FDA 510(k) record lists Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC-5390 Auto Hematology Analyzer?

The FDA product code for BC-5390 Auto Hematology Analyzer is GKZ.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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: GKZ)

K260781Yumizen H550HORIBA ABX SAS K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.