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 | AFP RIA KIT |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | ALERE, INC. |
| Date Received | 1982-06-22 |
| Decision Date | 1984-03-01 |
| PMA | P760001 |
| Supplement | S001 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALERE, INC. 10 Southgate Road scarborough, ME 04074 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P760001 | Original Filing | |
| S001 | 1982-06-22 | Normal 180 Day Track |