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} ESTROGEN ASSAY REAGENT |
| Generic Name | Kit, Assay, Estrogen Receptor |
| Applicant | ZEUS TECHNOLOGIES |
| Date Received | 1991-12-30 |
| Decision Date | 1992-04-17 |
| PMA | P860015 |
| Supplement | S002 |
| Product Code | LPJ |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |