K936229

Substantially Equivalent

AIA-PACK TT3 ASSAY

Applicant: Tosoh Medics, Inc.
Product code: CDP
Advisory panel: Clinical Chemistry
Date received: 1993-12-29
Decision date: 1994-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, 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.