IQ T4 IMMUNOASSAY— 510(k) K864560

Name: FDA 510(k) clearance K864560
Creator: U.S. Food and Drug Administration
Published: 1986-12-16

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K864560 for IQ T4 IMMUNOASSAY, Substantially Equivalent on 1986-12-16. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1986-11-19
Decision date: 1986-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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