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. |
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Device | ABBOTT ARCHITECT AUSAB |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD DEPT 9VA- AP8-1 ABBOTT PARK, IL 60064 |
PMA Number | P050051 |
Supplement Number | S003 |
Date Received | 09/29/2008 |
Decision Date | 11/13/2008 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGE OF GRAYZONE RANGE AND CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN. |
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