FDA 510(k)

QScout Lab; QScout RLD

Número K: K230878 · 2023-11-14

Data da decisão2023-11-14

Código do produtoGKZ

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

QScout Lab; QScout RLD is the device name listed in this FDA 510(k) record. The listed applicant is Ad Astra Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K230878. 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 QScout Lab; QScout RLD?

QScout Lab; QScout RLD is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Ad Astra Diagnostics, Inc.. The 510(k) number is K230878.

When did QScout Lab; QScout RLD receive FDA 510(k) clearance?

QScout Lab; QScout RLD received FDA 510(k) clearance on 2023-11-14, under 510(k) number K230878.

Who is the listed applicant for QScout Lab; QScout RLD?

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

What is the FDA product code for QScout Lab; QScout RLD?

The FDA product code for QScout Lab; QScout RLD 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.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) 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.