CEDIA TOTAL T3 ASSAY— 510(k) K904098

Name: FDA 510(k) clearance K904098
Creator: U.S. Food and Drug Administration
Published: 1990-09-27

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K904098 for CEDIA TOTAL T3 ASSAY, Substantially Equivalent on 1990-09-27. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1990-09-06
Decision date: 1990-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

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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.