DEW · Class II · 21 CFR 866.5510

FDA Product Code DEW: Igg, Antigen, Antiserum, Control

Leading manufacturers include Kent Laboratories, Inc., Icl Scientific and Dako Corp..

76
Total
76
Cleared
58d
Avg days
1976
Since
76 devices
25–48 of 76
Cleared Apr 22, 1987
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352
Helena Laboratories
Immunology · 16d
Cleared Sep 03, 1986
TINA-QUANT(R) IGG
K862764
Boehringer Mannheim Corp.
Immunology · 43d
Cleared Aug 25, 1986
DAKO ITA SYSTEM
K861059
Dako Corp.
Immunology · 159d
Cleared Jul 15, 1985
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541
Coulter Electronics, Inc.
Immunology · 90d
Cleared Jul 15, 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589
Abbott Laboratories
Immunology · 27d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Jun 22, 1984
OPTIMATE IGG TEST
K841816
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jan 24, 1984
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN
K833402
Technicon Instruments Corp.
Chemistry · 116d
Cleared Mar 24, 1983
TITAN IMMUNO-FIX
K830594
Helena Laboratories
Immunology · 28d
Cleared Feb 10, 1982
DAKO PAP KIT K505
K812484
Dako Corp.
Pathology · 163d
Cleared Oct 02, 1981
ACA IMMUNOGLOBULIN G ANALYTICAL TEST
K812664
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 11d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN G CALIBRATOR
K812630
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG
K812489
Dako Corp.
Immunology · 23d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA
K812495
Dako Corp.
Immunology · 23d
Cleared Jul 23, 1981
PHADEBAS IGG RAST TEST
K810694
Pharmacia, Inc.
Immunology · 129d
Cleared May 08, 1981
AIM SYSTEM (FOR IGG)
K811126
Icl Scientific
Immunology · 14d
Cleared Feb 09, 1981
IMMUNOLOGY CONTROL SERUM
K810056
Icl Scientific
Immunology · 27d
Cleared Jun 20, 1980
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI
K801281
J.T. Baker Chemical Co.
Immunology · 22d
Cleared May 08, 1980
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897
Icl Scientific
Immunology · 20d
Cleared Apr 24, 1980
GEMENI IGG ASSAY
K800451
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Feb 05, 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGG
K791403
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
ANTISERUM TO HUMAN IMMUNOGLOBULINS
K791824
Icl Scientific
Immunology · 33d
Cleared Sep 04, 1979
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702
Kent Laboratories, Inc.
Immunology · 145d