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.
Approval to add the cea test system to the opus plus and opus magnum analyzers. The same test system is used on all three instruments
| Device | OPUS(R) CEA TEST SYSTEM |
| Generic Name | System, Test, Carcinoembryonic Antigen |
| Applicant | BEHRING DIAGNOSTICS, INC. |
| Date Received | 1995-07-03 |
| Decision Date | 1996-02-23 |
| PMA | P920021 |
| Supplement | S001 |
| 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 | BEHRING DIAGNOSTICS, INC. 151 University Ave. westwood, MA 02090 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920021 | Original Filing | |
| S001 | 1995-07-03 | Normal 180 Day Track |