AFFINITY(TM) I UPTAKE IMMUNIT(TM)— 510(k) K865083

Name: FDA 510(k) clearance K865083
Creator: U.S. Food and Drug Administration
Published: 1987-07-09

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K865083 for AFFINITY(TM) I UPTAKE IMMUNIT(TM), Substantially Equivalent on 1987-07-09. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1986-12-30
Decision date: 1987-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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