This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | SENSITITRE |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. |
| Date Received | 1978-07-19 |
| Decision Date | 1979-05-04 |
| PMA | N50531 |
| Supplement | S |
| 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 |