Cleared Traditional

FIAX 100 FLUOROMETER

K843356 · Intl. Diagnostic Technology · Immunology
Sep 1984
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K843356 is an FDA 510(k) clearance for the FIAX 100 FLUOROMETER, a Fluorometer (Class I — General Controls, product code JZT), submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on September 17, 1984, 21 days after receiving the submission on August 27, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4520.

Submission Details

510(k) Number K843356 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1984
Decision Date September 17, 1984
Days to Decision 21 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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