FDA 510(k)

CRC-77tHR

Número K: K162394 · 2017-03-08

Data da decisão2017-03-08

Código do produtoKPT

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CRC-77tHR is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K162394. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CRC-77tHR?

CRC-77tHR is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Capintec, Inc.. The 510(k) number is K162394.

When did CRC-77tHR receive FDA 510(k) clearance?

CRC-77tHR received FDA 510(k) clearance on 2017-03-08, under 510(k) number K162394.

Who is the listed applicant for CRC-77tHR?

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

What is the FDA product code for CRC-77tHR?

The FDA product code for CRC-77tHR is KPT. This falls under the In Vitro Diagnostics category.

Outros registros que listam Capintec, Inc. como candidato(a)

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.

K192199CRC PC Smart Chamber K1

Dispositivos Relacionados (Código: KPT)

K192199CRC PC Smart Chamber K1Capintec, Inc.

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.