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 Street Suite 2300 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 06/14/2021 |
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
|
|
|