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

FDA 510(k) Cleared Igg, Antigen, Antiserum, Control Devices (Product Code DEW)

76 devices
1–24 of 76
Cleared Feb 08, 2005
TINA-QUANT IGG GEN.2
K050113
Roche Diagnostics Corp.
Immunology · 21d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617
Helena Laboratories
Immunology · 14d
Cleared Jan 18, 2000
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993928
Wako Chemicals USA, Inc.
Immunology · 61d
Cleared Nov 09, 1999
K-ASSAY IGG
K993281
Kamiya Biomedical Co.
Immunology · 40d
Cleared Nov 04, 1998
IGG
K983221
Abbott Laboratories
Immunology · 51d
Cleared Mar 06, 1997
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974
Beckman Instruments, Inc.
Immunology · 155d
Cleared Mar 06, 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108
Beckman Instruments, Inc.
Immunology · 76d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868
Beckman Instruments, Inc.
Immunology · 137d
Cleared Sep 26, 1996
QUANTEX IGG
K962202
Instrumentation Laboratory CO
Immunology · 111d
Cleared Apr 05, 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798
Randox Laboratories, Ltd.
Immunology · 105d
Cleared May 15, 1995
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
K951635
Beckman Instruments, Inc.
Immunology · 38d
Cleared Oct 03, 1994
BEHRING NEPHELOMETER II
K943997
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Apr 21, 1994
OT IGG SORBENT
K934324
Organon Teknika Corp.
Microbiology · 230d
Cleared Sep 08, 1993
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314
Bio-Rad
Immunology · 63d
Cleared Dec 15, 1992
ZORBA(TM) IGG REMOVAL REAGENT
K924197
Zeus Scientific, Inc.
Immunology · 117d
Cleared Apr 26, 1990
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943
Technicon Instruments Corp.
Immunology · 57d
Cleared Apr 18, 1989
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385
Vitek Systems, Inc.
Chemistry · 40d
Cleared Jul 08, 1988
QM300 IGG ANTIBODY PACK
K882083
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jun 06, 1988
WAKO(TM) IGG-HA DIRECT
K880784
Wako Chemicals USA, Inc.
Immunology · 101d
Cleared Feb 17, 1988
GULLSORB IGG INACTIVATION REAGENT
K875254
Gull Laboratories, Inc.
Immunology · 57d
Cleared Oct 13, 1987
IMMUNOGLOBULINS G
K873870
Unipath , Ltd.
Immunology · 50d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800
Abbott Laboratories
Immunology · 28d
Cleared Apr 22, 1987
QM300 IGG ANTIBODY PACK
K871340
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d

About Product Code DEW - Regulatory Context