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 | FLUORO-CEP (R) PROGESTERONE |
| Generic Name | Kit, Assay, Progesterone Receptor |
| Applicant | ZEUS SCIENTIFIC, INC. |
| Date Received | 1991-12-11 |
| Decision Date | 1992-04-21 |
| PMA | P900025 |
| Supplement | S001 |
| Product Code | LPI |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZEUS SCIENTIFIC, INC. 200 Evans Way branchburg, NJ 08876 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900025 | Original Filing | |
| S002 | 1991-12-30 | Normal 180 Day Track |
| S001 | 1991-12-11 | Normal 180 Day Track |