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FDA 510(k)

X100 with Full Field Peripheral Blood Smear (PBS) Application

N.º K: K201301 · 2020-10-02

SolicitanteScopio Labs , Ltd.
Fecha de decisión2020-10-02
Código de productoJOY
Comité asesorHE
DecisiónSubstantially Equivalent

Resumen del dispositivo

X100 with Full Field Peripheral Blood Smear (PBS) Application is the device name listed in this FDA 510(k) record. The listed applicant is Scopio Labs , Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201301. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the X100 with Full Field Peripheral Blood Smear (PBS) Application?

X100 with Full Field Peripheral Blood Smear (PBS) Application is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Scopio Labs , Ltd.. The 510(k) number is K201301.

When did X100 with Full Field Peripheral Blood Smear (PBS) Application receive FDA 510(k) clearance?

X100 with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201301.

Who is the listed applicant for X100 with Full Field Peripheral Blood Smear (PBS) Application?

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

What is the FDA product code for X100 with Full Field Peripheral Blood Smear (PBS) Application?

The FDA product code for X100 with Full Field Peripheral Blood Smear (PBS) Application is JOY.

Ensayos clínicos relacionados

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Otros registros que enlistan a Scopio Labs , Ltd. 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.

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationK220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

Dispositivos relacionados (Código: JOY)

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.

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc.K171315Aplicación Avanzada de RBCCellaVision AB

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.

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