Atlas FDA

Sight OLO

FDA 510(k) clearance K190898 · decided 2019-11-01

Clearance details

K-number
K190898
Device name
Sight OLO
Applicant
Sight Diagnostics , Ltd.
Decision
Substantially Equivalent
Date received
2019-04-05
Decision date
2019-11-01
Days to decision
210 days
Clearance type
Traditional
Product code
GKZ
Device class
2
Regulation number
864.5220
Medical specialty
Hematology
Advisory committee
Hematology
Location
Tel Aviv, IL
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Sight Diagnostics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
XR-Series (XR-10, XR-20) Automated Hematology Analyzers (K253212)Sysmex America, Inc.2026-05-27
Athelas Home (K243348)Athelas, Inc.2026-02-06
Tru Hematology Test (K251249)Truvian Sciences, Inc.2026-01-16
Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943)Sysmex America, Inc.2025-06-25
Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371)Sysmex America, Inc.2025-06-25
Alinity h-series System (K243283)Abbott Laboratories2025-02-20
Cito CBC System (K240402)Cytochip, Inc.2025-02-03
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (K240252)Beckman Coulter, Inc.2024-07-05
Yumizen H2500 (K232946)HORIBA ABX SAS2024-05-21
HemoScreen Hematology Analyzer (K240636)Pixcell Medical Technologies2024-05-02
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (K230887)Sysmex America, Inc.2023-12-21
QScout Lab; QScout RLD (K230878)Ad Astra Diagnostics, Inc.2023-11-14

Recalls involving this device

RecordFirmDate
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample prepa recall (Z-2173-2024)SIGHT DIAGNOSTICS LTD2024-06-21