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LTW — Susceptibility Test Cards, Antimicrobial Class II

FDA Device Classification

Classification Details

Product Code
LTW
Device Class
Class II
Regulation Number
866.1640
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K852613microtech medical systemsMIC-CONCEPT SYSTEMSeptember 20, 1985
K853685austin biological laboratoriesPRECEPT TM CARBENICILLINSeptember 16, 1985
K853273austin biological laboratoriesPRECEPT CEFTRIAXONESeptember 16, 1985
K853772austin biological laboratoriesPRECEPT METHICILLINSeptember 16, 1985
K853596austin biological laboratoriesPRECEPT CEFOPERAZONESeptember 16, 1985
K853689austin biological laboratoriesPRECEPT TM MOXALACTAMSeptember 13, 1985
K853686austin biological laboratoriesPRECEPT TM AMIKACINSeptember 13, 1985
K853684austin biological laboratoriesPRECEPT KANAMYCINSeptember 13, 1985
K853687austin biological laboratoriesPRECEPT NETILMICIN 32-13September 13, 1985
K853688austin biological laboratoriesPRECEPT TM TOBRAMYCINSeptember 13, 1985
K853263austin biological laboratoriesPRECEPT AVGMENTINAugust 29, 1985
K853053austin biological laboratoriesPRECEPT ERYTHROMYCINAugust 29, 1985
K850347analytical productsAPI UNISCEPT KBMarch 26, 1985
K844159analytical productsAPI UNISCEPT MIC 100ULDecember 14, 1984
K844231bd becton dickinson vacutainer systems preanalyticSCEPTOR BETA-LACTAM PLUS MIC PANELNovember 7, 1984
K843733analytical productsAPI UNISCEPT KBOctober 24, 1984