When did VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL) received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212849.

FDA 510(k)

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

Номер K: K212849 · 2022-02-04

ЗаявительBiomérieux, Inc.

Дата решения2022-02-04

Код продуктаLON

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux, Inc.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212849. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Biomérieux, Inc.. The 510(k) number is K212849.

When did VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212849.

Who is the listed applicant for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?

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

What is the FDA product code for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?

The FDA product code for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is LON.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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

Связанные устройства (Код: LON)

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.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.

Официальный источник

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