FDA 510(k) Applications for Medical Device Product Code "DFT"
(Igm, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983132 ABBOTT LABORATORIES IGM 11/04/1998
K842327 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. AMER. HISTO-ID SYS PRIMARY IGM S7920-31 08/02/1984
K945522 BECKMAN-DIAGNOSTIC SYSTEMS GROUP I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS 12/12/1994
K862762 BOEHRINGER MANNHEIM CORP. TINA-QUANT(R) IGM 09/08/1986
K800167 CALBIOCHEM-BEHRING CORP. IMMUNOGLOBULIN M REAGENT SYSTEM 02/05/1980
K812632 E.I. DUPONT DE NEMOURS & CO., INC. ACA IMMUNOGLOBIN M TEST PACK 09/29/1981
K832265 GELCO DIAGNOSTICS, INC. FITC GOAT ANTI-HUMAN IGM H CHAIN 10/31/1983
K832259 GELCO DIAGNOSTICS, INC. GOAT ANTI-HUMAN IGM H CHAIN 10/28/1983
K853469 GILFORD GILFORD IMMUNOGLOBULIN M REAGENT 09/16/1985
K871498 HELENA LABORATORIES TITAN GEL IMMUNOFIX CONTROLS 04/29/1987
K760673 HOECHST-ROUSSEL PHARMACEUTICALS, INC. RAPI/TEX-LGM KIT 12/19/1976
K760917 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN HAPTOGLOBIN TEST 12/30/1976
K811124 ICL SCIENTIFIC AIM SYSTEM (FOR IGM) 05/08/1981
K803251 ICL SCIENTIFIC AIP SYSTEM-METHOD FOR IGM 01/26/1981
K962201 INSTRUMENTATION LABORATORY CO. QUANTEX IGM 09/25/1996
K831608 INTL. DIAGNOSTIC TECHNOLOGY FIAX IGM TEST KIT 06/22/1983
K830606 ISOLAB, INC. QUIK-SEP IGM ISOLATION SYSTEM 03/24/1983
K901453 ISOLAB, INC. QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD 04/12/1990
K801282 J.T. BAKER CHEMICAL CO. J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA 06/30/1980
K872237 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. KALLESTAD QM300 IGM ANTIBODY PACK 07/09/1987
K770963 KALLESTAD LABORATORIES, INC. GOAT ANTISERUM IGM NEPHELOMHTRIC 06/24/1977
K772254 KALLESTAD LABORATORIES, INC. IMMUNOGLOBULIN M NEPHEL. ASSAY 12/22/1977
K855010 KALLESTAD LABORATORIES, INC. QUANTIMETRIC PLUS IGM REAGENT KIT 02/28/1986
K841814 MILES LABORATORIES, INC. OPTIMATE IGM TEST 06/22/1984
K884147 ORION DIAGNOSTICA, INC. IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M 10/27/1988
K760147 OXFORD LABORATORIES, INC. SERUM, IGM ANTI-HUMAN ACID 07/20/1976
K802177 PROTOS LABORATORIES GOAT ANTI-HUMAN IGM 10/31/1980
K955797 RANDOX LABORATORIES, LTD. IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR 04/05/1996
K894417 REAGENTS APPLICATIONS, INC. RAICHEM(TM) SPIA(TM) IGM REAGENTS 08/02/1989
K791402 SHERWOOD MEDICAL CO. LANCER L-INA ANTI-IGM 10/17/1979
K873871 UNIPATH LTD. IMMUNOGLOBULINS M 10/13/1987
K880828 WAKO CHEMICALS, USA, INC. WAKO(TM) IGM-HA DIRECT 03/25/1988
K831103 WORTHINGTON DIAGNOSTIC SYSTEMS TIA-IGM REAGENT & CALIBRATOR SETS 04/27/1983


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