K033038

Substantially Equivalent

GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688

Applicant: Beckman Coulter, Inc.
Product code: NIG
Advisory panel: Immunology
Date received: 2003-09-29
Decision date: 2003-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Adverse events under product code NIG

product code NIG

Malfunction: 618
Total: 618

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.