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 | CEA-ROCHE TEST KIT |
| Generic Name | System, Test, Carcinoembryonic Antigen |
| Applicant | HOFFMANN-LA ROCHE, INC. |
| Date Received | 1982-08-20 |
| Decision Date | 1982-09-16 |
| PMA | P800063 |
| Supplement | S002 |
| Product Code | DHX |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOFFMANN-LA ROCHE, INC. . nutley, NJ |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800063 | Original Filing | |
| S004 | 1982-12-15 | |
| S003 | 1982-09-15 | |
| S002 | 1982-08-20 | |
| S001 | 1981-09-11 |