FDA 510(k)

С user Translate this device_name medical-device regulatory document to Russian, while preserving company/product names, maintaining FDA, PMA, NCT links and PMID identifiers. Policy: medical-regulatory-v1. Return only the translation. ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Curve Materials.

Номер K: K153551 · 2016-08-04

ЗаявительAxis-Shield Diagnostics Limited

Дата решения2016-08-04

Код продуктаNHX

Консультативный комитетIM

РешениеSubstantially Equivalent

Описание устройства

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153551. The device is classified under product code NHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K153551.

When did ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. receive FDA 510(k) clearance?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153551.

Who is the listed applicant for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is NHX.

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.

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