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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K190898
Device Name Sight OLO
Applicant
Sight Diagnostics Ltd.
Derech Menachem Begin 23
Tel Aviv,  IL
Applicant Contact Sarah Levy
Correspondent
Hogan Lovells US LLP
1735 Market Street Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/05/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Clinical Trials NCT03595501
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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