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 | ENZYMUN TEST{R} CEA |
| Generic Name | System, Test, Carcinoembryonic Antigen |
| Applicant | BOEHRINGER MANNHEIM CORP. |
| Date Received | 1991-02-08 |
| Decision Date | 1993-07-29 |
| PMA | P860058 |
| 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 | BOEHRINGER MANNHEIM CORP. 9115 Hague Rd. indianapolis, IN 46250-0457 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860058 | Original Filing | |
| S001 | 1991-02-08 | Normal 180 Day Track |