AFFINITY TOTAL THYROXINE IMMUNIT— 510(k) K873518

Name: FDA 510(k) clearance K873518
Creator: U.S. Food and Drug Administration
Published: 1987-10-29

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K873518 for AFFINITY TOTAL THYROXINE IMMUNIT, Substantially Equivalent on 1987-10-29. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-09-01
Decision date: 1987-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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