THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM— 510(k) K844170

Name: FDA 510(k) clearance K844170
Creator: U.S. Food and Drug Administration
Published: 1984-12-11

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K844170 for THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM, Substantially Equivalent on 1984-12-11. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1984-10-25
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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