Cleared Traditional

QLIA IMMUNOCHEMISTRY SYSTEM

K883349 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology
Sep 1988
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K883349 is an FDA 510(k) clearance for the QLIA IMMUNOCHEMISTRY SYSTEM, a Fluorometer (Class I — General Controls, product code JZT), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 7, 1988, 29 days after receiving the submission on August 9, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4520.

Submission Details

510(k) Number K883349 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1988
Decision Date September 07, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JZT — Fluorometer
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.4520

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