FDA 510(k)

PhAST instrument and PhAST Blood Culture Gram-negative Panel

Номер K: K253316 · 2026-06-26

ЗаявительPhast Corp.

Дата решения2026-06-26

Код продуктаSAN

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

PhAST instrument and PhAST Blood Culture Gram-negative Panel is the device name listed in this FDA 510(k) record. The listed applicant is Phast Corp.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K253316. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the PhAST instrument and PhAST Blood Culture Gram-negative Panel?

PhAST instrument and PhAST Blood Culture Gram-negative Panel is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Phast Corp.. The 510(k) number is K253316.

When did PhAST instrument and PhAST Blood Culture Gram-negative Panel receive FDA 510(k) clearance?

PhAST instrument and PhAST Blood Culture Gram-negative Panel received FDA 510(k) clearance on 2026-06-26, under 510(k) number K253316.

Who is the listed applicant for PhAST instrument and PhAST Blood Culture Gram-negative Panel?

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

What is the FDA product code for PhAST instrument and PhAST Blood Culture Gram-negative Panel?

The FDA product code for PhAST instrument and PhAST Blood Culture Gram-negative Panel is SAN.

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: SAN)

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.K253573ASTar BC G- KitQ-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 K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC K221688ASTar BC G- Kit и ASTar ИнструментQ-Linea AB

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.