FDA.report

510(k) K211840

Device
Sight OLO
Applicant
S.D. Sight Diagnostics , Ltd.
510(k) number
K211840
Product code
GKZ
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-09
Date received
2021-06-14
Regulation
864.5220
Classification name
Counter, Differential Cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Sarah Levy
Address
23 Menachem Begin Rd. Tel Aviv IL 6618356 6618356

FDA Registration Numbers

Source Documents

510(k) summary PDF

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