MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT— 510(k) K920712

Name: FDA 510(k) clearance K920712
Creator: U.S. Food and Drug Administration
Published: 1992-03-27

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K920712 for MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT, Substantially Equivalent on 1992-03-27. Applicant: Medix Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Medix Biotech, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-02-18
Decision date: 1992-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

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