FDA 510(k)

Dropper hsCRP High Sensitivity CRP Control

Номер K: K152117 · 2016-04-21

Дата решения2016-04-21

Код продуктаJJX

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

Dropper hsCRP High Sensitivity CRP Control is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corporation. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152117. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Dropper hsCRP High Sensitivity CRP Control?

Dropper hsCRP High Sensitivity CRP Control is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Quantimetrix Corporation. The 510(k) number is K152117.

When did Dropper hsCRP High Sensitivity CRP Control receive FDA 510(k) clearance?

Dropper hsCRP High Sensitivity CRP Control received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152117.

Who is the listed applicant for Dropper hsCRP High Sensitivity CRP Control?

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

What is the FDA product code for Dropper hsCRP High Sensitivity CRP Control?

The FDA product code for Dropper hsCRP High Sensitivity CRP Control is JJX.

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: JJX)

K170678Beta-CrossLaps CalCheck 5Roche Diagnostics K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics K162514Multichem A1cTechnopath Manufacturing K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.

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.