RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE— 510(k) K810351

Name: FDA 510(k) clearance K810351
Creator: U.S. Food and Drug Administration
Published: 1981-02-23

Substantially Equivalent

Endocrine-Metabolic Center

FDA 510(k) clearance K810351 for RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE, Substantially Equivalent on 1981-02-23. Applicant: Endocrine-Metabolic Center. Device class: 2.

Clearance details

Applicant: Endocrine-Metabolic Center
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1981-02-10
Decision date: 1981-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-10051999-06-02
K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

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K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT1981-04-17
K800187 — EMC-M-175, THYROXINE - 100 TUBES1980-02-13

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.