510(k) K892500— CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE

Substantially Equivalent

Ciba Corning Diagnostics Corp.

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1989-04-13
Decision date: 1989-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.