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 | CIBA CORNING ACS PSA IMMUNOASSAY |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BAYER HEALTHCARE, LLC |
| Date Received | 1992-06-26 |
| Decision Date | 1998-12-08 |
| Notice Date | 1994-10-27 |
| PMA | P920030 |
| Supplement | S |
| Product Code | LTJ |
| Docket Number | 94M-0349 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER HEALTHCARE, LLC 511 Benedict Ave. tarrytown, NY 10591 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920030 | Original Filing | |
| S002 | 1998-04-20 | Panel Track |
| S001 | 1995-09-14 | Normal 180 Day Track |