DEW · Class II · 21 CFR 866.5510

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

Leading manufacturers include Beckman Instruments, Inc., Abbott Laboratories and Helena Laboratories.

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 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 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 Sep 08, 1993
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314
Bio-Rad
Immunology · 63d
Cleared Apr 26, 1990
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943
Technicon Instruments Corp.
Immunology · 57d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800
Abbott Laboratories
Immunology · 28d
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 Jul 15, 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589
Abbott Laboratories
Immunology · 27d
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 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 Oct 17, 1979
LANCER L-INA ANTI-IGG
K791403
Sherwood Medical Co.
Immunology · 79d

About Product Code DEW - Regulatory Context