510(k) K911634— MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST

Substantially Equivalent

Immunotech Corp.

Clearance details

Applicant: Immunotech Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1991-04-11
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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.