RUBELLA LATEX CARD TEST— 510(k) K811637

Name: FDA 510(k) clearance K811637
Creator: U.S. Food and Drug Administration
Published: 1981-08-13

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K811637 for RUBELLA LATEX CARD TEST, Substantially Equivalent on 1981-08-13. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code DOK
Device class: Class 2
Regulation: 21 CFR 862.3640
Advisory panel: Clinical Toxicology
Date received: 1981-06-10
Decision date: 1981-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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