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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 K201301
Device Name X100 with Full Field Peripheral Blood Smear (PBS) Application
Applicant
Scopio Labs , Ltd.
11 Tiomkin St., 2nd Floor
Tel Aviv,  IL 6578313
Applicant Contact Shahar Karny
Correspondent
Manatt Health
1 Embarcadero Center
30th Floor
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number864.5260
Classification Product Code
JOY  
Date Received05/15/2020
Decision Date 10/02/2020
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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