ANALYTE T4-THYROXINE— 510(k) K800385

Name: FDA 510(k) clearance K800385
Creator: U.S. Food and Drug Administration
Published: 1980-03-19

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K800385 for ANALYTE T4-THYROXINE, Substantially Equivalent on 1980-03-19. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1980-02-22
Decision date: 1980-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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