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JTT — Susceptibility Test Powders, Antimicrobial Class II

FDA Device Classification

Classification Details

Product Code
JTT
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
K983310accumed intlSENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACINDecember 17, 1998
K935805pasco laboratoriesPASCO MIC AND MIC/ID PANELSJune 13, 1994
K895362bd becton dickinson vacutainer systems preanalyticBACTEC PYRAZINAMIDE SUSCEPTIBILITY TESTDecember 1, 1989
K880574merck, sharp and dohmeMODIFIED IMIPENEM SUSCEPTIBILITY POWDERMay 4, 1988
K872081miles pharmaceuticalsCIPRO (TM) DIAGNOSTIC POWDERJune 15, 1987
K864442merck, sharp and dohmeNORFLOXACIN SUSCEPTIBILITY POWDERDecember 11, 1986
K860031organon teknikaGEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISKMarch 6, 1986
K855207difco laboratoriesIMIPENEM 10 MCG SENSITIVITY DISCSMarch 6, 1986
K855106bd becton dickinson vacutainer systems preanalyticIMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645March 6, 1986
K855071merck, sharp and dohmeIMIPENEM SUSCEPTIBILITY POWDERMarch 6, 1986
K830758miles laboratoriesAZLIN AZLOCILIN SODIUM-DIAG. REAGENTMay 25, 1983
K822866lilly research laboratoriesMOXALACTAMDecember 28, 1982
K822329bd becton dickinson vacutainer systems preanalyticANTITUBERCULOUS DRUGS (SIRE)September 2, 1982
K820578miles pharmaceuticalsMEZLIN DIAGNOSTIC REAGENTMay 12, 1982