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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
Generic NameSusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Date Received12/20/1976
Decision Date03/02/1978
Reclassified Date12/28/2001
Product Code LTW 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements: S073 S074 S075 S076 S077 S078 S079 S067 S068 S070 S071 S072 
S001 S002 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 
S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S051 S052 S057 S058 S059 
S061 S063 S064 S065 S066 S069  S142 S143 S144 S145 S087 
S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 S099 
S101 S102 S103 S104 S106 S107 S108 S110 S111 S112 S113 S114 
S115 S116 S082 S083 S084 S085 S086 S080 S081 S139 S140 S141 
S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 
S129 S130 S131 S132 S133 S134 S135 S136 S137 S138 S146 
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