Home / 510(k) Clearances / K243348

510(k) K243348

Athelas Home by Athelas, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2026
Date Received
October 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Athelas, Inc.

  • K200828 — Athelas Home (March 22, 2022)
  • K181288 — Athelas One (November 5, 2018)

Other clearances for product code GKZ

  • K251249 — Tru Hematology Test (January 16, 2026)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K240402 — Cito CBC System (February 3, 2025)
  • K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer I (July 5, 2024)
  • K232946 — Yumizen H2500 (May 21, 2024)
  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)
  • K230878 — QScout Lab; QScout RLD (November 14, 2023)