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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 K211840
Device Name Sight OLO
Applicant
S.D. Sight Diagnostics , Ltd.
23 Menachem Begin Rd.
Tel Aviv,  IL 6618356
Applicant Contact Sarah Levy
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/14/2021
Decision Date 05/09/2022
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
Recalls CDRH Recalls
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