Cleared Traditional

K842071 - FIAX TRANSFERRIN TEST KIT
(FDA 510(k) Clearance)

K842071 · Intl. Diagnostic Technology · Immunology device
Jul 1984
Decision
49d
Days
Class 2
Risk

K842071 is an FDA 510(k) clearance for the FIAX TRANSFERRIN TEST KIT. This device is classified as a Transferrin, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DDI).

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984, 49 days after receiving the submission on May 23, 1984.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K842071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1984
Decision Date July 11, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDI — Transferrin, Fitc, Antigen, Antiserum, Control
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.5880