510(k) K023239— AIA-PACK CA 19-9

Substantially Equivalent

Tosoh Corp.

Clearance details

Applicant: Tosoh Corp.
Product code: Code NIG
Advisory panel: Immunology
Date received: 2002-09-27
Decision date: 2002-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seymour, CT, 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.