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 | FLUORO-CEP{R} ESTROGEN ASSAY REAGENT |
| Generic Name | Kit, Assay, Estrogen Receptor |
| Applicant | ZEUS TECHNOLOGIES |
| Date Received | 1986-04-28 |
| Decision Date | 1988-02-29 |
| Notice Date | 1988-05-11 |
| PMA | P860015 |
| Supplement | S |
| Product Code | LPJ |
| Docket Number | 88M-0091 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZEUS TECHNOLOGIES p.o. Box 38 raritan, NJ 08869 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860015 | Original Filing | |
| S002 | 1991-12-30 | Normal 180 Day Track |
| S001 | 1991-12-11 | Normal 180 Day Track |