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 | AMERSHAM AFP |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | ORTHO CLINICAL DIAGNOSTICS |
| Date Received | 1985-10-31 |
| Decision Date | 1986-03-17 |
| PMA | P780006 |
| Supplement | S002 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHO CLINICAL DIAGNOSTICS 100 Indigo Creek Drive rochester, NY 14626-5101 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P780006 | Original Filing | |
| S003 | 1989-05-24 | Normal 180 Day Track |
| S002 | 1985-10-31 | |
| S001 |