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 | GONOSTICON DRI-DOT |
| Generic Name | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | ORGANON, INC. |
| Date Received | 1981-02-23 |
| Decision Date | 1981-04-14 |
| PMA | N17985 |
| Supplement | S001 |
| Product Code | JSX |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORGANON, INC. 9440 Telstar Avenue, Suite 7 el Monte, CA 91731 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17985 | Original Filing | |
| S002 | 1982-11-29 | |
| S001 | 1981-02-23 |