AUTOMATED RHEMATOID FACTOR TEST (ARFT)— 510(k) K800268

Name: FDA 510(k) clearance K800268
Creator: U.S. Food and Drug Administration
Published: 1980-02-21

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K800268 for AUTOMATED RHEMATOID FACTOR TEST (ARFT), Substantially Equivalent on 1980-02-21. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1980-02-06
Decision date: 1980-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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