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 | 1983-10-17 |
Decision Date | 1984-03-07 |
PMA | N50531 |
Supplement | S007 |
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 |