Sight OLO
Counter, Differential Cell
Sight Diagnostics Ltd.
The following data is part of a premarket notification filed by Sight Diagnostics Ltd. with the FDA for Sight Olo.
Pre-market Notification Details
| Device ID | K190898 |
| 510k Number | K190898 |
| Device Name: | Sight OLO |
| Classification | Counter, Differential Cell |
| Applicant | Sight Diagnostics Ltd. Derech Menachem Begin 23 Tel Aviv, IL |
| Contact | Sarah Levy |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, PA 19103 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-11-01 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B787OLOU10 | K190898 | 000 |
Trademark Results [Sight OLO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGHT OLO 79228698 5552784 Live/Registered |
S.D. SIGHT DIAGNOSTICS LTD. 2018-01-09 |
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