Cleared Traditional

IGA

K983359 · Abbott Laboratories · Immunology
Nov 1998
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K983359 is an FDA 510(k) clearance for the IGA, a Iga, Antigen, Antiserum, Control (Class II — Special Controls, product code CZP), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on November 4, 1998, 41 days after receiving the submission on September 24, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K983359 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1998
Decision Date November 04, 1998
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

Similar Devices — CZP Iga, Antigen, Antiserum, Control

All 53
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525 · HORIBA ABX SAS · Jun 2020
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · Beckman Coulter, Inc. · Feb 2006
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · Roche Diagnostics Corp. · Mar 2004
N LATEX IGA
K024038 · Dade Behring, Inc. · Feb 2003
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
K993927 · Wako Chemicals USA, Inc. · Jan 2000
QUANTEX IGA
K962200 · Instrumentation Laboratory CO · Sep 1996