FERRITIN IMMUNORADIOMETRIC ASSAY KIT— 510(k) K823829

Name: FDA 510(k) clearance K823829
Creator: U.S. Food and Drug Administration
Published: 1983-03-11

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K823829 for FERRITIN IMMUNORADIOMETRIC ASSAY KIT, Substantially Equivalent on 1983-03-11. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code DFB
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 1982-12-20
Decision date: 1983-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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