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JTO — Discs, Strips And Reagents, Microorganism Differentiation Class I

FDA Device Classification

Classification Details

Product Code
JTO
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050352ameritek researchIN-VITRO DIAGNOSTIC VAGINITIS TEST KITSeptember 1, 2005
K970832remelPYR SWABApril 24, 1997
K970834remelGRAM SWABApril 17, 1997
K970833remelINDOLE SWABApril 2, 1997
K970009microbiologicsLYFO(TM) DIFFERENTIAL DISK-BACITRACINFebruary 6, 1997
K962966innovative diagnostic systemsIDS RAPID CB PLUS SYSTEMOctober 8, 1996
K961191hardy diagnosticsCOLISCREENJune 17, 1996
K960996hardy diagnosticsM. CAT BUTYRATE DISKApril 18, 1996
K955826gibson laboratoriesGIBSON ID-M. CAT.February 29, 1996
K954783difco laboratoriesDRYSLIDE CARTARRHALISFebruary 6, 1996
K954812microbiologicsLYFO(TM) DIFFERIENTAL DISK-PYRDecember 20, 1995
K953247gibson laboratoriesGIBSON ID A.E. TESTNovember 20, 1995
K951889microbiologicsLYFO(TM) DIFFERENTIAL DISKAugust 24, 1995
K950346oxis intlB-L RED(TM) DISCSMay 5, 1995
K945882microbiologicsLYFO(TM) DIFFERENTIAL DISK-BILEApril 24, 1995
K945881microbiologicsLYFO(TM) DIFFERENTIAL DISK-STERILE DISKApril 24, 1995
K945883microbiologicsLYFO(TM) DIFFERENTIAL DISK-BILE ESCULINApril 24, 1995
K945880microbiologicsLYFO(TM) DIFFERENTIAL DISK-SPSApril 24, 1995
K934130e-y laboratoriesSWABZYME OXIDASESeptember 14, 1994
K940162e-y laboratoriesGONOCHEK II REAGENT TUBESSeptember 9, 1994