FDA 510(k)

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

Número K: K232276 · 2023-10-06

RequerenteOxoid Limited (Part of Thermo Fisher Scientific)

Data da decisão2023-10-06

Código do produtoJTN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232276. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K232276.

When did Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232276.

Who is the listed applicant for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

The FDA 510(k) record lists Oxoid Limited (Part of Thermo Fisher Scientific) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

The FDA product code for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is JTN.

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

Outros registros que listam Oxoid Limited (Part of Thermo Fisher Scientific) como candidato(a)

K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 K203336Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 K210873Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 K193508Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: JTN)

K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy Diagnostics K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics

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.