IGOXIN SOLID PHASE RIA— 510(k) K771638

Name: FDA 510(k) clearance K771638
Creator: U.S. Food and Drug Administration
Published: 1977-10-07

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K771638 for IGOXIN SOLID PHASE RIA, Substantially Equivalent on 1977-10-07. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1977-08-26
Decision date: 1977-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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