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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 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.

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. 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.

Other records listing Scopio Labs , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: JOY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K171315Advanced RBC ApplicationCellaVision AB

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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