DGO · Class II · 21 CFR 866.5510

FDA Product Code DGO: Ige, Peroxidase, Antigen, Antiserum, Control

Leading manufacturers include Diagnostic Products Corp., Beckman Instruments, Inc. and Calbiochem-Behring Corp..

15
Total
15
Cleared
78d
Avg days
1980
Since

FDA 510(k) Cleared Ige, Peroxidase, Antigen, Antiserum, Control Devices (Product Code DGO)

15 devices
1–15 of 15
Cleared Feb 23, 1995
IMMULITE(R) ALLERGY FOOD PANEL FP5E
K943194
Diagnostic Products Corp.
Immunology · 233d
Cleared Sep 14, 1992
IGE EIA TEST KIT
K920087
The Binding Site, Ltd.
Immunology · 250d
Cleared Apr 17, 1991
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
K911511
Diagnostic Products Corp.
Immunology · 13d
Cleared Jul 14, 1989
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
K894039
Quidel Corp.
Immunology · 38d
Cleared Jun 16, 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125
Beckman Instruments, Inc.
Immunology · 52d
Cleared Sep 10, 1987
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
K872801
Diagnostic Products Corp.
Immunology · 57d
Cleared Mar 28, 1986
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851
Nichols Institute Diagnostics
Immunology · 21d
Cleared Oct 14, 1983
EPSILON IGE TEST KIT
K831987
Beckman Instruments, Inc.
Microbiology · 115d
Cleared May 14, 1980
IMMUNOGLOBULIN E TEST KIT
K800995
Calbiochem-Behring Corp.
Immunology · 19d

About Product Code DGO - Regulatory Context