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KLB — Radioimmunoassay, Tobramycin Class II

FDA Device Classification

Classification Details

Product Code
KLB
Device Class
Class II
Regulation Number
862.3900
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060853roche diagnosticsONLINE TDM TOBRAMYCINJune 9, 2006
K012312diagnostic productsIMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)August 20, 2001
K003341syva co., dade behringEMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSJanuary 22, 2001
K904304e.i. dupont de nemours and coDUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHODOctober 26, 1990
K903192instrumentation laboratoryIL TOBRAMYCIN ASSAYAugust 22, 1990
K893913technicon instrumentsTECHNICON RA SYSTEMS TOBRAMYCIN TEST METHODAugust 21, 1989
K882294syvaEMIT CONVENIENCE PACK: TOBRAMYCIN ASSAYJuly 1, 1988
K874223syvaEMIT TOBRAMYCIN ASSAYNovember 13, 1987
K854184clinical dataIN-VITRO TEST DETERMINATION OF TOBRAMYCINDecember 4, 1985
K852671e.i. dupont de nemours and coACA TOBRAMY-CIN ANALYTICAL TEST PACKJuly 22, 1985
K832763biosan laboratoriesTOBRAMYCIN REAGENTMarch 23, 1984
K832985e.i. dupont de nemours and coTOBRAMYCIN ANALYTICAL TEST PACK-ACAOctober 27, 1983
K822858diagnostic productsCOAT-A-COUNT TOBRAMYCIN RIA KITOctober 18, 1982
K813516microanalytic researchMRI TOBRAMYCIN RIA KITDecember 29, 1981
K812415kallestad laboratoriesKALLESTAD ANTISERA TO TOBRAMYCINSeptember 9, 1981
K810597bd becton dickinson vacutainer systems preanalyticMACRO-VUE CARD TESTMarch 17, 1981
K810011alpha gamma laboratoryGAMMA STICK 125-1 TOBRAMYCIN RIA KITJanuary 28, 1981
K800743antibodiesTOBRAMYCIN RIA KITApril 16, 1980
K791596bio-radFLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAYOctober 17, 1979
K791502bio-radQUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNOSeptember 4, 1979