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 | BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC |
| Generic Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| Date Received | 1982-10-13 |
| Decision Date | 1983-03-01 |
| PMA | P800030 |
| Supplement | S002 |
| Product Code | LON |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 Eye St. Nw Ste. 625 washington, DC 20006 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800030 | Original Filing | |
| S006 | 1984-02-08 | |
| S005 | 1983-01-19 | |
| S004 | 1983-01-07 | |
| S003 | 1982-10-04 | |
| S002 | 1982-10-13 | |
| S001 | 1981-06-08 |