Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Glocyte Automated Cell Counter System

Número K: K152776 · 2016-05-27

RequerenteAdvanced Instruments, Inc.
Data da decisão2016-05-27
Código do produtoGKL
Comité consultivoHE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Glocyte Automated Cell Counter System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instruments, Inc.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K152776. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Glocyte Automated Cell Counter System?

Glocyte Automated Cell Counter System is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is Advanced Instruments, Inc.. The 510(k) number is K152776.

When did Glocyte Automated Cell Counter System receive FDA 510(k) clearance?

Glocyte Automated Cell Counter System received FDA 510(k) clearance on 2016-05-27, under 510(k) number K152776.

Who is the listed applicant for Glocyte Automated Cell Counter System?

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

What is the FDA product code for Glocyte Automated Cell Counter System?

The FDA product code for Glocyte Automated Cell Counter System is GKL.

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_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

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.

↑