AIA-PACK FT4— 510(k) K913493

Substantially Equivalent

Tosoh Corp.

FDA 510(k) clearance K913493 for AIA-PACK FT4, Substantially Equivalent on 1991-09-10. Applicant: Tosoh Corp..

Clearance details

Applicant: Tosoh Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1991-08-06
Decision date: 1991-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.