When did VITEK 2 AST-Gram Negative Cefazolin (= 32 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Negative Cefazolin (= 32 µg/mL) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251579.

FDA 510(k)

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

Número K: K251579 · 2025-08-21

RequerentebioMerieux, Inc.

Data da decisão2025-08-21

Código do produtoLON

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K251579. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)?

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is bioMerieux, Inc.. The 510(k) number is K251579.

When did VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251579.

Who is the listed applicant for VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)?

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

What is the FDA product code for VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)?

The FDA product code for VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) is LON.

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 bioMerieux, Inc. como candidato(a)

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST System K260282VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance K234012VITEK COMPACT PRO K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)K240279VIDAS TBI (GFAP, UCH-L1)

Ver todos os 65 dispositivos →

Dispositivos Relacionados (Código: LON)

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company K234012VITEK COMPACT PRObioMerieux, Inc.K250344BD Phoenix™ Automated Microbiology SystemBecton, Dickinson and Company

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.