FDA 510(k)

Access Total ßhCG (5th IS)

Número K: K221990 · 2022-12-27

Data da decisão2022-12-27

Código do produtoDHA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Access Total ßhCG (5th IS) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K221990. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Access Total ßhCG (5th IS)?

Access Total ßhCG (5th IS) is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K221990.

When did Access Total ßhCG (5th IS) receive FDA 510(k) clearance?

Access Total ßhCG (5th IS) received FDA 510(k) clearance on 2022-12-27, under 510(k) number K221990.

Who is the listed applicant for Access Total ßhCG (5th IS)?

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

What is the FDA product code for Access Total ßhCG (5th IS)?

The FDA product code for Access Total ßhCG (5th IS) is DHA.

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 Beckman Coulter, Inc. como candidato(a)

K262109Access NT-proBNP K252169Access BNP II K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access Rubella IgG

Ver todos os 73 dispositivos →

Dispositivos Relacionados (Código: DHA)

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Kit de Reagente Total ß-hCG Alinity i, Sistemas GLP TrackAbbott Laboratories K230790Kit de Reagente Total B-hCG Alinity i, Kit de Reagente de Glicose Alinity c, Disolvente de Amostra ICT Alinity c, Série Alinity ciAbbott Laboratories K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.K203227Elecsys HCG STATRoche 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.