FDA 510(k)

Kenota 1 Total IgE; Kenota 1 (instrument)

Número K: K231151 · 2024-05-31

Data da decisão2024-05-31

Código do produtoDGC

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kenota 1 Total IgE; Kenota 1 (instrument) is the device name listed in this FDA 510(k) record. The listed applicant is Kenota, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K231151. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kenota 1 Total IgE; Kenota 1 (instrument)?

Kenota 1 Total IgE; Kenota 1 (instrument) is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Kenota, Inc.. The 510(k) number is K231151.

When did Kenota 1 Total IgE; Kenota 1 (instrument) receive FDA 510(k) clearance?

Kenota 1 Total IgE; Kenota 1 (instrument) received FDA 510(k) clearance on 2024-05-31, under 510(k) number K231151.

Who is the listed applicant for Kenota 1 Total IgE; Kenota 1 (instrument)?

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

What is the FDA product code for Kenota 1 Total IgE; Kenota 1 (instrument)?

The FDA product code for Kenota 1 Total IgE; Kenota 1 (instrument) is DGC.

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: DGC)

K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur IgE Total (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia AB

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.