This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| 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 | 1978-10-12 |
| Decision Date | 1984-06-07 |
| Notice Date | 1984-07-06 |
| PMA | P780006 |
| Supplement | S |
| Product Code | LOK |
| Docket Number | 84M-0227 |
| 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 |