Ab Biodisk

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
64
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLJuly 24, 2008
K052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBICOctober 13, 2005
K042392DAPTOMYCINDecember 13, 2004
K042390ETEST FOR GEMIFLOXACINNovember 19, 2004
K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGJuly 27, 2004
K021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAEJune 6, 2002
K020748ETEST ERTAPENEMApril 29, 2002
K010363ETEST MEROPENEMApril 9, 2001
K002139ETEST LINEZOLIDNovember 8, 2000
K001547ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIPAugust 7, 2000
K000596ETEST GATIFLOXACINMay 22, 2000
K000298ETEST MOXIFLOXACINMay 18, 2000
K992993ETEST FOR QUINUPRISTIN/DALFOPRISTINNovember 16, 1999
K990722ETEST FOR CEFUROXIMEApril 22, 1999
K990685TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)March 26, 1999
K990297ETEST MINOCYCLINEMarch 22, 1999
K984491SYSTEM U3 FOR CEFUROXIMEMarch 9, 1999
K984581SYSTEM U3 FOR CEPHALOTHINMarch 9, 1999
K983890SYSTEM U3February 18, 1999
K984144SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACIDFebruary 9, 1999