SIGHT DIAGNOSTICS LTD
FDA Regulatory Profile
SIGHT DIAGNOSTICS LTD appears in FDA public data with 4 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2173-2024, Class II) was initiated on May 13, 2024. Its most recent 510(k) clearance was granted on November 1, 2019.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2173-2024 | Class II | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation too | May 13, 2024 |
| Z-1469-2022 | Class II | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 | June 14, 2022 |
| Z-0963-2022 | Class II | The Sight OLO device is a computer vision based platform for blood analysis. The platform combines | January 20, 2022 |
| Z-2517-2021 | Class II | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 | March 17, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190898 | Sight OLO | November 1, 2019 |