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 | CA 125 ANTIBODY RIA |
| Generic Name | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | CENTOCOR, INC. |
| Date Received | 1993-12-08 |
| Decision Date | 1994-12-21 |
| PMA | P850009 |
| Supplement | S007 |
| Product Code | LTK |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CENTOCOR, INC. 200 Great Valley Pkwy. malvern, PA 19355-1307 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850009 | Original Filing | |
| S007 | 1993-12-08 | Normal 180 Day Track |
| S006 | 1993-09-15 | Normal 180 Day Track |
| S005 | 1992-01-23 | Normal 180 Day Track |
| S004 | 1990-11-28 | Normal 180 Day Track |
| S003 | ||
| S002 | 1989-10-27 | Normal 180 Day Track |
| S001 | 1987-06-08 | Normal 180 Day Track |