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510(k) K211840

Sight OLO by S.D. Sight Diagnostics , Ltd. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2022
Date Received
June 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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