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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K220013
Device Name X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Applicant
Scopio Labs Ltd.
10 HaSharon
Tel Aviv,  IL 6618502
Applicant Contact Shahar Karny
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact Randy J. Prebula
Regulation Number864.5260
Classification Product Code
JOY  
Date Received01/04/2022
Decision Date 05/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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