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.
Approval for the addition of a limitation to use an alternative method for testing of proteus mirabilis and enterobacter spp. With the antibiotic cefazolin in either the minimal inhibitory concentration (mic) or the breakpoint panels.
| Device | MICROSCAN RAPID FLUOROGENIC PANELS |
| Classification Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | DADE INTL., INC. |
| Date Received | 1999-01-04 |
| Decision Date | 1999-01-25 |
| PMA | P870049 |
| Supplement | S028 |
| Product Code | LON |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DADE INTL., INC. 1584 Enterprise Blvd. west Sacramento,, CA 95691 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870049 | Original Filing | |
| S032 | 2001-11-05 | Normal 180 Day Track |
| S031 | 2001-10-12 | Special (immediate Track) |
| S030 | 2000-05-17 | Special (immediate Track) |
| S029 | 1999-06-10 | Special (immediate Track) |
| S028 | 1999-01-04 | Special (immediate Track) |
| S027 | 1998-06-09 | Special (immediate Track) |
| S026 | ||
| S025 | 1995-09-28 | Normal 180 Day Track |
| S024 | 1995-08-01 | Normal 180 Day Track |
| S023 | 1995-02-22 | Normal 180 Day Track |
| S022 | 1994-09-30 | Special (immediate Track) |
| S021 | 1994-09-13 | Special (immediate Track) |
| S020 | 1993-10-20 | Special (immediate Track) |
| S019 | ||
| S018 | 1993-04-21 | Normal 180 Day Track |
| S017 | ||
| S016 | 1992-01-08 | Normal 180 Day Track |
| S015 | 1991-11-29 | Normal 180 Day Track |
| S014 | 1991-08-22 | Normal 180 Day Track |
| S013 | 1991-06-28 | Normal 180 Day Track |
| S012 | 1991-05-21 | Normal 180 Day Track |
| S011 | 1991-05-17 | Normal 180 Day Track |
| S010 | 1990-11-21 | Normal 180 Day Track |
| S009 | 1990-11-07 | Normal 180 Day Track |
| S008 | 1990-10-25 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 1989-12-26 | Normal 180 Day Track |
| S004 | 1989-07-20 | Normal 180 Day Track |
| S003 | 1989-03-20 | Normal 180 Day Track |
| S002 | 1989-03-02 | Normal 180 Day Track |
| S001 | 1988-12-13 | Normal 180 Day Track |