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 |
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 | S002 |
Date Received | 10/19/2007 |
Decision Date | 12/05/2007 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN AND CHANGE OF GRAYZONE RANGE. |
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