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 | AB-CORE K HEPATITIS B CORE ANTIGEN 125I |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | SORIN BIOMEDICA, FIAT, USA, INC. |
| Date Received | 1986-08-01 |
| Decision Date | 1986-10-31 |
| PMA | P850044 |
| Supplement | S002 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SORIN BIOMEDICA, FIAT, USA, INC. fiat Usa Inc. 375 Park Ave. ny, NY 10152 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850044 | Original Filing | |
| S003 | 1986-11-18 | Normal 180 Day Track |
| S002 | 1986-08-01 | Normal 180 Day Track |
| S001 | 1986-07-03 | Normal 180 Day Track |