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FDA 510(k)

X100 with Full Field Peripheral Blood Smear (PBS) Application

K-Number: K201301 · 2020-10-02

ApplicantScopio Labs , Ltd.
Decision Date2020-10-02
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Scopio Labs , Ltd.. The 510(k) number is K201301.

When was X100 with Full Field Peripheral Blood Smear (PBS) Application approved by the FDA?

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

What company makes X100 with Full Field Peripheral Blood Smear (PBS) Application?

X100 with Full Field Peripheral Blood Smear (PBS) Application is manufactured by Scopio Labs , Ltd..

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.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Scopio Labs , Ltd.

K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application DEN230034X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

Related Devices (Code: JOY)

K171315Advanced RBC ApplicationCellaVision AB K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc. K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd. K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd. K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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