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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVITEK SYSTEMS "GENERAL SUSCEPTIBILITY CARD"
Classification Namesusceptibility test cards, antimicrobial
Generic Namegeneral susceptibility card
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
PMA NumberN50510
Date Received12/20/1976
Decision Date03/02/1978
Reclassified Date 12/28/2001
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: 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 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S081 S082 S083 S084 S085 
S086 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 S117 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S127 S128 S129 S130 S131 S132 S133 
S134 S135 S136 S137 S138 S139 S140 S141 S142 
S143 S144 S145 S146 
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