ARIA II 125 I CORTISOL— 510(k) K802380

Name: FDA 510(k) clearance K802380
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K802380 for ARIA II 125 I CORTISOL, Substantially Equivalent on 1980-10-31. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1980-10-01
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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