Note: 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 | EBK |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE PO BOX 285 STILLWATER, MN 55082-0285 |
PMA Number | P870048 |
Supplement Number | S001 |
Date Received | 10/05/1990 |
Decision Date | 01/10/1991 |
Withdrawal Date
|
09/18/2007 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
|
|