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 expanded gentamicin dilutions at concentrations of 0. 12-4, 6, and 8ug/ml, the removal of the limitation for the testing of salmonella/shigella with gentamicin, and additional limitations for the testing of acinetobacter baumanii and stenotrophomonas maltophilia with gentamicin
| Device | MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | DADE INTL., INC. |
| Date Received | 1995-09-28 |
| Decision Date | 1996-05-03 |
| PMA | P870049 |
| Supplement | S025 |
| Product Code | LON |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |