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 | ARCHITECT HBSAG/CONFIRMATORY |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064 |
PMA Number | P060007 |
Supplement Number | S015 |
Date Received | 05/25/2011 |
Decision Date | 06/24/2011 |
Withdrawal Date
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01/09/2014 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS. |
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