510(k) K190898 ยท GKZ Counter, Differential Cell
Sight OLO
| Applicant | Sight Diagnostics , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Nov 1, 2019 |
| Received | Apr 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2024 | SIGHT DIAGNOSTICS LTD Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer. Open, Classified |
GKZ | None listed |
| Jun 14, 2022 | SIGHT DIAGNOSTICS LTD Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 Open, Classified |
GKZ | None listed |
| Jan 20, 2022 | SIGHT DIAGNOSTICS LTD The Sight OLO device is a computer vision based platform for blood analysis. The platform
combines computer-vision algorithms for image processing to identify and quantify blood
components (e.g., red Open, Classified |
GKZ | None listed |
| Mar 17, 2021 | SIGHT DIAGNOSTICS LTD Sight OLO-E1/U1 Software and Operators Manual
Software v2.56.1
Catalog #: 1 OLO-U1
Catalog #: 2 OLO-E1
revision 1.9, revision 1.10 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.