ARIA II INSULIN RIA— 510(k) K811144

Name: FDA 510(k) clearance K811144
Creator: U.S. Food and Drug Administration
Published: 1981-05-15

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K811144 for ARIA II INSULIN RIA, Substantially Equivalent on 1981-05-15. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1981-04-27
Decision date: 1981-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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