AUTOLYZER 800— 510(k) K841852

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..

Clearance details

Applicant: Geometric Data, Div. Smithkline Corp.
Product code: Code GKZ
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 ↗

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.