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(R) EIA |
| Generic Name | System, Test, Carcinoembryonic Antigen |
| Applicant | ROCHE DIAGNOSTICS GMBH |
| Date Received | 1988-05-17 |
| Decision Date | 1988-07-07 |
| PMA | P840027 |
| Supplement | S003 |
| Product Code | DHX |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS GMBH 1080 U.s. Hwy. 202 branchburg Township somerville, NJ 08876-3771 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840027 | Original Filing | |
| S006 | 1989-04-11 | Normal 180 Day Track |
| S005 | 1989-04-11 | Normal 180 Day Track |
| S004 | 1988-10-27 | Normal 180 Day Track |
| S003 | 1988-05-17 | Normal 180 Day Track |
| S002 | 1986-08-19 | Normal 180 Day Track |
| S001 | 1986-06-17 | Special (immediate Track) |