DFT · Class II · 21 CFR 866.5550

FDA Product Code DFT: Igm, Antigen, Antiserum, Control

Leading manufacturers include Kallestad Laboratories, Inc., Icl Scientific and Isolab, Inc..

33
Total
33
Cleared
46d
Avg days
1976
Since

FDA 510(k) Cleared Igm, Antigen, Antiserum, Control Devices (Product Code DFT)

33 devices
1–24 of 33
Cleared Nov 04, 1998
IGM
K983132
Abbott Laboratories
Immunology · 57d
Cleared Sep 25, 1996
QUANTEX IGM
K962201
Instrumentation Laboratory CO
Immunology · 110d
Cleared Apr 05, 1996
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 12, 1990
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K901453
Isolab, Inc.
Immunology · 16d
Cleared Aug 02, 1989
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417
Reagents Applications, Inc.
Chemistry · 16d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
K884147
Orion Diagnostica, Inc.
Chemistry · 24d
Cleared Mar 25, 1988
WAKO(TM) IGM-HA DIRECT
K880828
Wako Chemicals USA, Inc.
Immunology · 24d
Cleared Oct 13, 1987
IMMUNOGLOBULINS M
K873871
Unipath , Ltd.
Immunology · 50d
Cleared Jul 09, 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 29d
Cleared Apr 29, 1987
TITAN GEL IMMUNOFIX CONTROLS
K871498
Helena Laboratories
Immunology · 13d
Cleared Sep 08, 1986
TINA-QUANT(R) IGM
K862762
Boehringer Mannheim Corp.
Immunology · 48d
Cleared Feb 28, 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010
Kallestad Laboratories, Inc.
Immunology · 74d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Jun 22, 1984
OPTIMATE IGM TEST
K841814
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1983
FIAX IGM TEST KIT
K831608
Intl. Diagnostic Technology
Immunology · 35d
Cleared Mar 24, 1983
QUIK-SEP IGM ISOLATION SYSTEM
K830606
Isolab, Inc.
Chemistry · 27d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN M TEST PACK
K812632
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared May 08, 1981
AIM SYSTEM (FOR IGM)
K811124
Icl Scientific
Immunology · 14d
Cleared Jan 26, 1981
AIP SYSTEM-METHOD FOR IGM
K803251
Icl Scientific
Immunology · 34d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Feb 05, 1980
IMMUNOGLOBULIN M REAGENT SYSTEM
K800167
Calbiochem-Behring Corp.
Immunology · 11d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGM
K791402
Sherwood Medical Co.
Immunology · 79d
Cleared Dec 22, 1977
IMMUNOGLOBULIN M NEPHEL. ASSAY
K772254
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Jun 24, 1977
GOAT ANTISERUM IGM NEPHELOMHTRIC
K770963
Kallestad Laboratories, Inc.
Immunology · 28d

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