PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE— 510(k) K844171

Name: FDA 510(k) clearance K844171
Creator: U.S. Food and Drug Administration
Published: 1984-12-10

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K844171 for PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE, Substantially Equivalent on 1984-12-10. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LGR
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1984-10-25
Decision date: 1984-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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