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DFT — Igm, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DFT
Device Class
Class II
Regulation Number
866.5550
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K983132abbott laboratoriesIGMNovember 4, 1998
K962201instrumentation laboratoryQUANTEX IGMSeptember 25, 1996
K955797randox laboratoriesIGM IMMUNOTRUBIDIMETRIC & CALIBRATORApril 5, 1996
K945522beckman-diagnostic systems groupI.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSDecember 12, 1994
K901453isolabQUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODApril 12, 1990
K894417reagents applicationsRAICHEM(TM) SPIA(TM) IGM REAGENTSAugust 2, 1989
K884147orion diagnosticaIMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOctober 27, 1988
K880828wako chemicals usaWAKO(TM) IGM-HA DIRECTMarch 25, 1988
K873871unipathIMMUNOGLOBULINS MOctober 13, 1987
K872237kallestad diag, a div. of erbamontKALLESTAD QM300 IGM ANTIBODY PACKJuly 9, 1987
K871498helena laboratoriesTITAN GEL IMMUNOFIX CONTROLSApril 29, 1987
K862762boehringer mannheimTINA-QUANT(R) IGMSeptember 8, 1986
K855010kallestad laboratoriesQUANTIMETRIC PLUS IGM REAGENT KITFebruary 28, 1986
K853469gilfordGILFORD IMMUNOGLOBULIN M REAGENTSeptember 16, 1985
K842327bartels immunodiagnostic suppliesAMER. HISTO-ID SYS PRIMARY IGM S7920-31August 2, 1984
K841814miles laboratoriesOPTIMATE IGM TESTJune 22, 1984
K832265gelco diagnosticsFITC GOAT ANTI-HUMAN IGM H CHAINOctober 31, 1983
K832259gelco diagnosticsGOAT ANTI-HUMAN IGM H CHAINOctober 28, 1983
K831608intl. diagnostic technologyFIAX IGM TEST KITJune 22, 1983
K831103worthington diagnostic systemsTIA-IGM REAGENT & CALIBRATOR SETSApril 27, 1983