Cleared Traditional

FIAX IGA TEST KIT

K831607 · Intl. Diagnostic Technology · Immunology
Jun 1983
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K831607 is an FDA 510(k) clearance for the FIAX IGA TEST KIT, a Iga, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code CZN), submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983, 35 days after receiving the submission on May 18, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K831607 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1983
Decision Date June 22, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZN — Iga, Fitc, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CZN Iga, Fitc, Antigen, Antiserum, Control

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
K891683 · Helena Laboratories · Apr 1989
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011 · Kallestad Laboratories, Inc. · Feb 1986
OPTIMATE IGA TEST
K841815 · Miles Laboratories, Inc. · Jun 1984
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262 · Gelco Diagnostics, Inc. · Oct 1983
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
K832257 · Gelco Diagnostics, Inc. · Oct 1983
RABBIT ANTISERUM TO HUMAN IGA
K831909 · Dako Corp. · Jul 1983