TOTAL T3 CHEMILUMINESCENCE ASSAY— 510(k) K923015

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K923015 for TOTAL T3 CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1992-09-02. Applicant: Nichols Institute Diagnostics.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1992-06-22
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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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.