510(k) K011953— WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

Substantially Equivalent

Wiener Laboratories Saic

Clearance details

Applicant: Wiener Laboratories Saic
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2001-06-21
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, Santa Fe, AR

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.