FDA.report

510(k) K243283

Device
Alinity h-series System
Applicant
Abbott Laboratories
510(k) number
K243283
Product code
GKZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-20
Date received
2024-10-17
Regulation
864.5220
Classification name
Counter, Differential Cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Saloni Shah
Address
4551 Great America Pkwy. Santa Clara CA US 95054 95054

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GKZ

510(k)DeviceApplicantDecision date
K243348Athelas HomeAthelas, Inc.2026-02-06
K251249Tru Hematology TestTruvian Sciences, Inc.2026-01-16
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.2025-06-25
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.2025-06-25
K240402Cito CBC SystemCytochip, Inc.2025-02-03
K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis SystemBeckman Coulter, Inc.2024-07-05
K232946Yumizen H2500HORIBA ABX SAS2024-05-21
K240636HemoScreen Hematology AnalyzerPixcell Medical Technologies2024-05-02
K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerSysmex America, Inc.2023-12-21
K230878QScout Lab; QScout RLDAd Astra Diagnostics, Inc.2023-11-14
K222148HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.2023-08-16
K220031Alinity h-series SystemAbbott Laboratories2023-08-04
K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc.2022-11-08
K211840Sight OLOS.D. Sight Diagnostics , Ltd.2022-05-09
K200828Athelas HomeAthelas, Inc.2022-03-22