510(k) K211840 ยท GKZ Counter, Differential Cell
Sight OLO
| Applicant | S.D. Sight Diagnostics , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, May 9, 2022 |
| Received | Jun 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211840
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.