COAT-A-COUNT FREE THYROXINE KIT/COMPONEN— 510(k) K822882

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K822882 for COAT-A-COUNT FREE THYROXINE KIT/COMPONEN, Substantially Equivalent on 1982-11-05. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1982-09-21
Decision date: 1982-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.