UBI MAGIWEL THYROXINE (T4) QUANTITATIVE— 510(k) K962211

Name: FDA 510(k) clearance K962211
Creator: U.S. Food and Drug Administration
Published: 1996-07-08

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K962211 for UBI MAGIWEL THYROXINE (T4) QUANTITATIVE, Substantially Equivalent on 1996-07-08. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1996-06-10
Decision date: 1996-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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