UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE— 510(k) K961236

Name: FDA 510(k) clearance K961236
Creator: U.S. Food and Drug Administration
Published: 1996-05-30

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K961236 for UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE, Substantially Equivalent on 1996-05-30. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1996-03-29
Decision date: 1996-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
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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K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE1998-02-09
K973153 — UBI MAGIWEL AMPHETAMINE METABOLITES1997-10-28
K973155 — UBI MAGIWEL OPIATE METABOLITES1997-10-28

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.