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 | OMNISCEPT(TM) KB SYSTEM |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | ANALYTICAL PRODUCTS, INC. |
| Date Received | 1982-12-03 |
| Decision Date | 1983-07-05 |
| PMA | P800029 |
| Supplement | S005 |
| Product Code | LON |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANALYTICAL PRODUCTS, INC. 200 Express Street plainview , NY 11803- |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800029 | Original Filing | |
| S010 | 1984-04-17 | |
| S009 | 1984-04-05 | |
| S008 | 1983-08-23 | |
| S007 | 1983-06-28 | |
| S006 | ||
| S005 | 1982-12-03 | |
| S004 | ||
| S003 | 1982-05-12 | |
| S002 | 1981-06-19 | |
| S001 | 1981-02-12 |