Sight OLO
FDA 510(k) clearance K211840 · decided 2022-05-09
Clearance details
- K-number
- K211840
- Device name
- Sight OLO
- Applicant
- S.D. Sight Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-14
- Decision date
- 2022-05-09
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample prepa recall (Z-2173-2024) | SIGHT DIAGNOSTICS LTD | 2024-06-21 |