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 | HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ORGANON TEKNIKA CORP. |
| Date Received | 1989-08-25 |
| Decision Date | 1990-03-21 |
| PMA | P840070 |
| Supplement | S001 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORGANON TEKNIKA CORP. 100 Akzo Ave. durham, NC 27712 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840070 | Original Filing | |
| S001 | 1989-08-25 | Normal 180 Day Track |