TECHNICON DAX SYSTEM THYROXINE (T4) METHOD— 510(k) K922945

Name: FDA 510(k) clearance K922945
Creator: U.S. Food and Drug Administration
Published: 1992-10-14

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K922945 for TECHNICON DAX SYSTEM THYROXINE (T4) METHOD, Substantially Equivalent on 1992-10-14. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-06-18
Decision date: 1992-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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