Cleared Traditional

FIAX IGG TEST

K832821 · Intl. Diagnostic Technology · Immunology
Oct 1983
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K832821 is an FDA 510(k) clearance for the FIAX IGG TEST, a Total Spinal-fluid, Antigen, Antiserum, Control (Class I — General Controls, product code DFI), submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983, 56 days after receiving the submission on August 19, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5860.

Submission Details

510(k) Number K832821 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1983
Decision Date October 14, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DFI — Total Spinal-fluid, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5860