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

FDA 510(k) K220013 · Scopio Labs , Ltd.

Substantially Equivalent

510(k) numberK220013

Submission

Device name
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Applicant
Scopio Labs , Ltd.
Tel Aviv, IL
Received
January 4, 2022
Decision date
May 3, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOY – Device, Automated Cell-Locating
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5260
Specialty
Hematology

Other 510(k)s with product code JOY

510(k)DeviceApplicantDecision
K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.06/27/2025SE
K221309AI100 with ShonitJOY · Traditional Sigtuple Technologies Pvt. , Ltd.09/19/2023SE
K200595CellaVision DC-1, CellaVision DC-1 PPAJOY · Traditional CellaVision AB10/16/2020SE
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.10/02/2020SE
K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional Sysmex America, Inc.10/30/2018SE
K171315Advanced RBC ApplicationJOY · Traditional CellaVision AB08/01/2017SE
K102778Cellavision DM1200 with the Body Fluid ApplictionJOY · Traditional CellaVision AB09/16/2011SE
K092116Easycell Cell LocatorJOY · Traditional Medica Corp.05/12/2010SE
K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127JOY · Special CellaVision AB11/20/2009SE
K080595Cellavision DM96 with the Body Fluid ApplicationJOY · Traditional CellaVision AB12/05/2008SE

More from CellaVision AB

510(k)DeviceDecision
K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional 06/27/2025SE
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional 10/02/2020SE

Questions and answers

When was X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application cleared by the FDA?

X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (K220013) received a 510(k) decision of Substantially Equivalent on May 3, 2022, 119 days after the submission was received.

What is the product code of K220013?

The FDA product code is JOY – Device, Automated Cell-Locating, a Class II (moderate risk) device regulated under 21 CFR 864.5260.