K905214

Substantially Equivalent

IMMULITE (TM) TOTAL T3

Applicant: Cirrus Diagnostics, Inc.
Product code: CDP
Advisory panel: Clinical Chemistry
Date received: 1990-11-20
Decision date: 1991-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NJ, 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.