FDA 510(k)

3MTM AttestTM Rápido 5 Test Pack de Vapor-Plus

Número K: K200536 · 2020-06-01

Data da decisão2020-06-01

Código do produtoFRC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is 3M Complany. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K200536. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is 3M Complany. The 510(k) number is K200536.

When did 3MTM AttestTM Rapid 5 Steam-Plus Test Pack receive FDA 510(k) clearance?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack received FDA 510(k) clearance on 2020-06-01, under 510(k) number K200536.

Who is the listed applicant for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

The FDA 510(k) record lists 3M Complany as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

The FDA product code for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack is FRC.

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: FRC)

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation K251122Terragene® Bionova® BT20 Biological IndicatorTerragene K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)Steris K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS Corporation K250061Celerity IncubatorSTERIS Corporation

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.