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} AFP |
| Generic Name | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | BOEHRINGER MANNHEIM CORP. |
| Date Received | 1990-06-19 |
| Decision Date | 1990-08-03 |
| PMA | P860044 |
| Supplement | S001 |
| Product Code | LOJ |
| 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 |
|---|---|---|
| P860044 | Original Filing | |
| S003 | 1990-12-24 | Normal 180 Day Track |
| S002 | 1990-09-11 | Normal 180 Day Track |
| S001 | 1990-06-19 | Normal 180 Day Track |