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.
| Device | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD |
| Classification Name | Susceptibility Test Cards, Antimicrobial |
| Generic Name | Susceptibility Test Cards, Antimicrobial |
| Applicant | BIOMERIEUX VITEK, INC. |
| Date Received | 1994-03-03 |
| Decision Date | 1995-03-01 |
| PMA | N50510 |
| Supplement | S061 |
| Product Code | LTW |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |