CONTEXT FILTER— 510(k) K791108

Name: FDA 510(k) clearance K791108
Creator: U.S. Food and Drug Administration
Published: 1979-07-17

Substantially Equivalent

Geometric Data, Div. Smithkline Corp.

FDA 510(k) clearance K791108 for CONTEXT FILTER, Substantially Equivalent on 1979-07-17. 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: 1979-06-14
Decision date: 1979-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

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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.

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K841852 — AUTOLYZER 8001984-09-05
K811534 — HEMASPINNER1981-08-18
K791041 — HEMATRAK ABNORMAL RECOGNITION1979-09-04
K790816 — HEMATRAK MODEL 4801979-07-17
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.