FDA 510(k)

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Número K: K230675 · 2024-06-20

Data da decisão2024-06-20

Código do produtoSAN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is the device name listed in this FDA 510(k) record. The listed applicant is Specific Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K230675. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Specific Diagnostics, LLC. The 510(k) number is K230675.

When did VITEK REVEAL GN AST Assay and VITEK REVEAL AST System receive FDA 510(k) clearance?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System received FDA 510(k) clearance on 2024-06-20, under 510(k) number K230675.

Who is the listed applicant for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

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

What is the FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

The FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is SAN.

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: SAN)

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.K253316PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp.K253573Kit G- Kit do ASTar BCQ-Linea AB K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K221688Kit G- Kit do ASTar BC e Instrumento ASTarQ-Linea 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.