THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM— 510(k) K904816

Name: FDA 510(k) clearance K904816
Creator: U.S. Food and Drug Administration
Published: 1991-01-17

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K904816 for THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM, Substantially Equivalent on 1991-01-17. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1990-10-24
Decision date: 1991-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

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