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 | SENSITITRE |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. |
| Date Received | 1980-05-19 |
| Decision Date | 1980-08-13 |
| PMA | N50531 |
| Supplement | S003 |
| Product Code | LON |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TREK DIAGNOSTIC SYSTEMS, INC. 210 Business Park Dr. sun Prairie, WI 53590 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N50531 | Original Filing | |
| S007 | 1983-10-17 | |
| S006 | 1982-10-20 | |
| S005 | 1981-11-02 | |
| S004 | 1981-01-30 | |
| S003 | 1980-05-19 | |
| S002 | ||
| S001 |