VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN

FDA Premarket Approval N50510 S104

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the addition of the antibiotic gentamicin at concentrations of 4, 16, and 32 ug/ml to the viteck 2 gram negative susceptibility test system. The device, as modified, will be marketed under the trade name vitek 2 and is indicated for use in vitek 2 gram negative susceptibility test cards for the susceptibility testing of gram negative isolates to gentamicin in the range of =16 ug/ml.

DeviceVITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN
Generic NameSusceptibility Test Cards, Antimicrobial
ApplicantBIOMERIEUX VITEK, INC.
Date Received1999-08-20
Decision Date2000-01-06
PMAN50510
SupplementS104
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BIOMERIEUX VITEK, INC. 595 Anglum Dr. hazelwood, MO 63042-2395

Supplemental Filings

Supplement NumberDateSupplement Type
N50510Original Filing
S146 2001-09-17 Special (immediate Track)
S145 2001-04-16 Normal 180 Day Track
S144 2001-01-03 Normal 180 Day Track
S143 2000-12-18 Normal 180 Day Track
S142 2000-12-18 Normal 180 Day Track
S141 2000-11-16 Normal 180 Day Track
S140 2000-11-16 Normal 180 Day Track
S139 2000-04-12 Normal 180 Day Track
S138 2000-04-10 Normal 180 Day Track
S137 2000-04-10 Normal 180 Day Track
S136 2000-04-06 Normal 180 Day Track
S135 2000-04-06 Normal 180 Day Track
S134 2000-04-06 Normal 180 Day Track
S133 2000-04-05 Normal 180 Day Track
S132 2000-04-05 Normal 180 Day Track
S131 2000-04-05 Normal 180 Day Track
S130 2000-04-03 Normal 180 Day Track
S129 2000-03-09 Normal 180 Day Track
S128 2000-03-09 Normal 180 Day Track
S127 1999-10-25 Normal 180 Day Track
S126 1999-10-25 Normal 180 Day Track
S125 1999-10-25 Normal 180 Day Track
S124 1999-10-14 Normal 180 Day Track
S123 1999-10-14 Normal 180 Day Track
S122 1999-10-12 Normal 180 Day Track
S121 1999-10-08 Normal 180 Day Track
S120 1999-10-06 Normal 180 Day Track
S119 1999-09-30 Normal 180 Day Track
S118 1999-09-30
S117 1999-09-27
S116 1999-09-15 Normal 180 Day Track
S115 1999-09-13 Normal 180 Day Track
S114 1999-09-13 Normal 180 Day Track
S113 1999-08-30 Normal 180 Day Track
S112 1999-08-30 Normal 180 Day Track
S111 1999-08-30 Normal 180 Day Track
S110 1999-08-25 Normal 180 Day Track
S109
S108 1999-08-25 Normal 180 Day Track
S107 1999-08-25 Normal 180 Day Track
S106 1999-08-20 Normal 180 Day Track
S105
S104 1999-08-20 Normal 180 Day Track
S103 1999-08-11 Normal 180 Day Track
S102 1999-08-05 Normal 180 Day Track
S101 1999-08-05 Normal 180 Day Track
S100
S099 1999-08-02 Normal 180 Day Track
S098 1999-07-28 Normal 180 Day Track
S097 1999-07-28 Normal 180 Day Track
S096 1999-07-23 Normal 180 Day Track
S095 1999-07-22 Normal 180 Day Track
S094 1999-07-22 Normal 180 Day Track
S093 1999-07-22 Normal 180 Day Track
S092 1999-07-14 Normal 180 Day Track
S091 1999-07-02 Normal 180 Day Track
S090 1999-07-02 Normal 180 Day Track
S089 1999-05-24 Normal 180 Day Track
S088 1999-05-24 Normal 180 Day Track
S087 1999-05-24 Normal 180 Day Track
S086 1999-03-16 Normal 180 Day Track
S085 1998-09-09 Normal 180 Day Track
S084 1998-08-18 Normal 180 Day Track
S083 1998-07-09 Normal 180 Day Track
S082 1998-07-01 Normal 180 Day Track
S081 1998-04-22 Normal 180 Day Track
S080 1998-04-01 Special (immediate Track)
S079 1997-08-29 Normal 180 Day Track
S078 1997-10-06 Normal 180 Day Track
S077
S076 1997-01-13 Normal 180 Day Track
S075 1997-01-15 Normal 180 Day Track
S074 1997-01-13 Normal 180 Day Track
S073 1996-12-23 Normal 180 Day Track
S072 1996-11-20 Normal 180 Day Track
S071 1996-09-09 Normal 180 Day Track
S070 1996-03-29 Special (immediate Track)
S069 1995-06-06 Normal 180 Day Track
S068 1995-04-24 Normal 180 Day Track
S067 1995-03-22 Normal 180 Day Track
S066 1994-10-04
S065 1994-09-26 Normal 180 Day Track
S064
S063 1994-08-08 Normal 180 Day Track
S062
S061 1994-03-03 Normal 180 Day Track
S060
S059 1993-08-04 Normal 180 Day Track
S058 1993-04-27 Normal 180 Day Track
S057 1993-04-09 Normal 180 Day Track
S056
S055
S054
S053
S052 1992-12-22 Normal 180 Day Track
S051 1992-06-25 Normal 180 Day Track
S050
S049
S048
S047
S046 1991-04-03 Normal 180 Day Track
S045 1990-06-27 Normal 180 Day Track
S044 1990-06-22 Normal 180 Day Track
S043 1990-06-05 Normal 180 Day Track
S042 1990-04-03 Normal 180 Day Track
S041 1989-09-06 Normal 180 Day Track
S040 1988-12-05 Normal 180 Day Track
S039 1988-11-23 Normal 180 Day Track
S038 1988-09-15 Normal 180 Day Track
S037 1988-08-31 Normal 180 Day Track
S036 1988-08-15 Normal 180 Day Track
S035 1988-08-09 Normal 180 Day Track
S034 1988-07-12 Normal 180 Day Track
S033 1988-06-21 Normal 180 Day Track
S032
S031 1987-11-09 Normal 180 Day Track
S030 1987-11-02 Normal 180 Day Track
S029 1987-09-08 Normal 180 Day Track
S028 1987-05-26 Normal 180 Day Track
S027 1987-04-14 Normal 180 Day Track
S026 1987-04-14 Normal 180 Day Track
S025 1986-07-29 Normal 180 Day Track
S024 1986-03-28
S023 1986-02-19
S022 1985-12-05
S021 1985-10-21
S020 1985-08-30
S019 1985-02-15
S018 1984-12-26
S017 1984-12-04
S016
S015 1984-11-01
S014 1984-11-01
S013 1984-10-22
S012 1984-08-13
S011 1984-07-30
S010 1984-07-16
S009 1984-07-02
S008 1984-06-25
S007 1984-06-14
S006 1982-01-28
S005 1980-03-28
S004
S003
S002 1979-05-02
S001 1979-04-24

NIH GUDID Devices

Device IDPMASupp
03573026617967 N50510 000
03573026617943 N50510 000
03573026463533 N50510 082
03573026619060 N50510 082
03573026555504 N50510 082
03573026049782 N50510 084
03573026162375 N50510 084
03573026162351 N50510 084
03573026206765 N50510 084
03573026145804 N50510 084
03573026206789 N50510 084
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