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 to confirm results for the testing of staphylococcus spp. With the antibiotic vancomycin. The device, as modified, will be marketed under the trade name microscan(r) rapid fluorogenic.
| Device | MICROSCAN(R) 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 | 1998-06-09 |
| Decision Date | 1998-06-30 |
| PMA | P870049 |
| Supplement | S027 |
| 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 |