FDA 510(k)

CRC-77tHR

N.º K: K162394 · 2017-03-08

Fecha de decisión2017-03-08

Código de productoKPT

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Otros registros que enlistan a Capintec, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K192199CRC PC Smart Chamber K1

Dispositivos relacionados (Código: KPT)

K192199CRC PC Smart Chamber K1Capintec, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.