AUTOLYZER 800— 510(k) K841852

Name: FDA 510(k) clearance K841852
Creator: U.S. Food and Drug Administration
Published: 1984-09-05

Substantially Equivalent

Geometric Data, Div. Smithkline Corp.

FDA 510(k) clearance K841852 for AUTOLYZER 800, Substantially Equivalent on 1984-09-05. Applicant: Geometric Data, Div. Smithkline Corp.. Device class: 2.

Clearance details

Applicant: Geometric Data, Div. Smithkline Corp.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1984-05-03
Decision date: 1984-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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 Geometric Data, Div. Smithkline Corp.

view all

K811534 — HEMASPINNER1981-08-18
K791041 — HEMATRAK ABNORMAL RECOGNITION1979-09-04
K790816 — HEMATRAK MODEL 4801979-07-17
K791108 — CONTEXT FILTER1979-07-17
K790042 — STAIN, HEMASTAIN RETIC1979-02-15

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.