Sight OLO

510(k)K190898HematologyGKZ

Sight Diagnostics Ltd. is listed for Sight OLO (K190898). The FDA list gives November 1, 2019 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GKZ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190898

Official FDA database record

Date of final decision: November 1, 2019
Company on the FDA list: Sight Diagnostics Ltd.
Lead panel: Hematology
Primary product code: GKZ
openFDA device name for the code: Counter, Differential Cell
Device class: 2
Regulation number: 864.5220
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary