ClearanceBrief
Panels › Immunology › Product code DEW · Class 2

Igg, Antigen, Antiserum, Control

Regulation 866.5510

0510(k)s in 12 months (76 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in DEW

Company510(k)sRecalls
Kent Laboratories, Inc.50
Abbott Laboratories31
Beckman Instruments, Inc.40
Dako Corp.40
Icl Scientific40
Beckman Coulter Inc03
Diagnostica, Inc.30
Helena Laboratories30
E.I. Dupont DE Nemours & Co., Inc.20
Gelco Diagnostics, Inc.20
Decided510(k)Device and applicantCode
Sep 23, 1981K812453SCRIPPSYSTEM IMMUNOGLOBIN RID KIT
Scripps-Miles, Inc.
DEW
Sep 8, 1981K812328SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
Scripps-Miles, Inc.
DEW
Jul 23, 1981K810694PHADEBAS IGG RAST TEST
Pharmacia, Inc.
DEW
May 8, 1981K811126AIM SYSTEM (FOR IGG)
Icl Scientific
DEW
Feb 9, 1981K810056IMMUNOLOGY CONTROL SERUM
Icl Scientific
DEW
Oct 31, 1980K802257GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC
Protos Laboratories
DEW
Jun 20, 1980K801281J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI
J.T. Baker Chemical Co.
DEW
May 8, 1980K800897RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
Icl Scientific
DEW
Apr 24, 1980K800451GEMENI IGG ASSAY
Electro-Nucleonics Laboratories, Inc.
DEW
Mar 12, 1980K800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
Diagnostica, Inc.
DEW
Feb 5, 1980K800119IMMUNOGLOBULIN G REAGENT SYSTEM
Calbiochem-Behring Corp.
DEW
Nov 27, 1979K791281ANTI-HUMAN IGG SERUM
Diagnostica, Inc.
DEW
Oct 17, 1979K791824ANTISERUM TO HUMAN IMMUNOGLOBULINS
Icl Scientific
DEW
Oct 17, 1979K791403LANCER L-INA ANTI-IGG
Sherwood Medical Co.
DEW
Oct 17, 1979K791285ANTI-HUMAN GLOBULINS
Diagnostica, Inc.
DEW
Sep 4, 1979K790702ANTISERUM, HUMAN, IGG H & L CHAIN
Kent Laboratories, Inc.
DEW
Apr 12, 1979K790704ANTISERUM TO HUMAN IGG
Kent Laboratories, Inc.
DEW
Feb 3, 1978K772077RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
Gelman Instrument Co.
DEW
Dec 22, 1977K772252IMMUNOGLOBULIN G NEPHEL. ASSAY
Kallestad Laboratories, Inc.
DEW
Jun 24, 1977K770961GOAT ANTISERUM IGG NEPHELOMETRIC
Kallestad Laboratories, Inc.
DEW
Apr 28, 1977K770669RHODAMINE-CONJUGATED ANTISERUM
Kent Laboratories, Inc.
DEW
Apr 28, 1977K770668FLUORESCEIN CONJUGATED ANTISERUM
Kent Laboratories, Inc.
DEW
Apr 28, 1977K770597DASP TM ANTI-RABBIT
Organon, Inc.
DEW
Apr 7, 1977K761224ULTRA LOW LEVEL IMMUNOGLOBULIN G
Intl. Diagnostic Technology
DEW
Mar 21, 1977K770484FLUOR. CONJUGATED ANTISERUM
Kent Laboratories, Inc.
DEW
Jul 19, 1976K760145SERUM, IGG GOAT ANTI-HUMAN ACID
Oxford Laboratories, Inc.
DEW

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