COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.— 510(k) K874838

Name: FDA 510(k) clearance K874838
Creator: U.S. Food and Drug Administration
Published: 1988-02-19

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K874838 for COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT., Substantially Equivalent on 1988-02-19. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1987-11-24
Decision date: 1988-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

view all

K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K243348 — Athelas Home2026-02-06
K251249 — Tru Hematology Test2026-01-16
K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

More clearances from Coulter Electronics, Inc.

view all

K923951 — CD8 CYTOSPHERES KIT1994-04-25
K930119 — COULTER RETIC-C CELL CONTROL1993-04-05
K921279 — CD4 CYTOSPHERES KIT1992-12-29
K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.