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.
Replacement of the current radiolabeled afp with a new afp antigen
| Device | QUANTITOPE 125I AFP KIT AND CONTROL SERUM |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | Bio-Rad Laboratories, Inc. |
| Date Received | 1995-12-21 |
| Decision Date | 1996-10-02 |
| PMA | P800025 |
| Supplement | S005 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bio-Rad Laboratories, Inc. 3 Boulevard Raymond Poincare' marnes-la-coquette 92430 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800025 | Original Filing | |
| S005 | 1995-12-21 | Normal 180 Day Track |
| S004 | 1986-03-18 | |
| S003 | 1985-04-01 | |
| S002 | ||
| S001 | 1984-01-26 |