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FDA 510(k)

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

N.º K: K243144 · 2025-06-27

SolicitanteScopio Labs , Ltd.
Fecha de decisión2025-06-27
Código de productoJOY
Comité asesorHE
DecisiónSubstantially Equivalent

Resumen del dispositivo

X100/X100HT 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 2025-06-27 under 510(k) number K243144. 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/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Scopio Labs , Ltd.. The 510(k) number is K243144.

When did X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application receive FDA 510(k) clearance?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243144.

Who is the listed applicant for X100/X100HT 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/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

The FDA product code for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is JOY.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationK201301X100 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.

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 ABK201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K182062Sysmex 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 →

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