ARIA II 125- I-ESTRIOL SYSTEM— 510(k) K801735

Name: FDA 510(k) clearance K801735
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K801735 for ARIA II 125- I-ESTRIOL SYSTEM, Substantially Equivalent on 1980-09-16. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1980-07-25
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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