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 | AUTOBAC MIC TEST SYSTEM |
| Classification Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | ORGANON TEKNIKA CORP. |
| Date Received | 1988-03-21 |
| Decision Date | 1988-07-07 |
| PMA | N50524 |
| 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 | ORGANON TEKNIKA CORP. 100 Akzo Ave. durham, NC 27712 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N50524 | Original Filing | |
| S035 | 1989-10-04 | Normal 180 Day Track |
| S034 | ||
| S033 | 1989-07-24 | Normal 180 Day Track |
| S032 | 1989-04-05 | Normal 180 Day Track |
| S031 | 1988-10-25 | Normal 180 Day Track |
| S030 | 1988-09-01 | Normal 180 Day Track |
| S029 | 1988-08-09 | Normal 180 Day Track |
| S028 | 1988-07-01 | Normal 180 Day Track |
| S027 | 1988-06-23 | Special (immediate Track) |
| S026 | 1988-05-11 | Normal 180 Day Track |
| S025 | 1988-03-21 | Normal 180 Day Track |
| S024 | 1988-02-09 | Normal 180 Day Track |
| S023 | 1988-01-25 | Normal 180 Day Track |
| S022 | 1988-01-11 | Normal 180 Day Track |
| S021 | 1987-11-03 | Normal 180 Day Track |
| S020 | 1985-10-15 | |
| S019 | 1984-03-28 | |
| S018 | 1984-01-05 | |
| S017 | ||
| S016 | 1983-11-30 | |
| S015 | ||
| S014 | 1983-09-13 | |
| S013 | 1983-07-12 | |
| S012 | 1983-02-15 | |
| S011 | 1982-03-12 | |
| S010 | 1982-01-12 | |
| S009 | 1981-12-01 | |
| S008 | 1980-11-10 | |
| S007 | 1980-09-29 | |
| S006 | 1980-03-17 | |
| S005 | 1980-03-17 | |
| S004 | 1980-01-14 | |
| S003 | 1980-01-14 | |
| S002 | 1979-06-21 | |
| S001 | 1979-09-10 |