FDA 510(k)

InTray GC

Número K: K210511 · 2021-10-20

RequerenteBiomed Diagnostics Incorporated

Data da decisão2021-10-20

Código do produtoJTY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

InTray GC is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Diagnostics Incorporated. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K210511. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InTray GC?

InTray GC is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Biomed Diagnostics Incorporated. The 510(k) number is K210511.

When did InTray GC receive FDA 510(k) clearance?

InTray GC received FDA 510(k) clearance on 2021-10-20, under 510(k) number K210511.

Who is the listed applicant for InTray GC?

The FDA 510(k) record lists Biomed Diagnostics Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InTray GC?

The FDA product code for InTray GC is JTY.

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

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.