Cleared Traditional

QUANTICLONE IGE RADIOIMMUNASSAY

K852268 · Kallestad Laboratories, Inc. · Immunology
Jul 1985
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K852268 is an FDA 510(k) clearance for the QUANTICLONE IGE RADIOIMMUNASSAY, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on July 10, 1985, 43 days after receiving the submission on May 28, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K852268 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1985
Decision Date July 10, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

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

Similar Devices — DGC Ige, Antigen, Antiserum, Control

All 113
Kenota 1 Total IgE; Kenota 1 (instrument)
K231151 · Kenota, Inc. · May 2024
Quantia IgE
K214068 · Biokit, S.A. · Feb 2023
Total Immunoglobulin E (IgE)
K220178 · Beckman Coulter, Inc. · Mar 2022
ADVIA Centaur Total IgE (tIgE)
K193493 · Siemens Healthcare Diagnostics, Inc. · Jan 2020
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
K161899 · Phadia AB · Jul 2016
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
K133404 · Phadia AB · Feb 2014