SIGHT DIAGNOSTICS LTD

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2173-2024Class IISight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tooMay 13, 2024
Z-1469-2022Class IISight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1June 14, 2022
Z-0963-2022Class IIThe Sight OLO device is a computer vision based platform for blood analysis. The platform combines January 20, 2022
Z-2517-2021Class IISight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2March 17, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K190898Sight OLONovember 1, 2019