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.
| Device | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD |
| Classification Name | Susceptibility Test Cards, Antimicrobial |
| Generic Name | Susceptibility Test Cards, Antimicrobial |
| Applicant | BIOMERIEUX VITEK, INC. |
| Date Received | 1976-12-20 |
| Decision Date | 1978-03-02 |
| PMA | N50510 |
| Supplement | S |
| Product Code | LTW |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOMERIEUX VITEK, INC. 595 Anglum Dr. hazelwood, MO 63042-2395 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N50510 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 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 |