510(k) K991252— AIA-PACK FT3 ASSAY

Substantially Equivalent

Tosoh Medics, Inc.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1999-04-13
Decision date: 1999-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.