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 HBE DIAGNOSTIC KIT |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. DEPT: 09VA BLDG: AP6C-2 ABBOTT PARK, IL 60064-3500 |
PMA Number | P790025 |
Supplement Number | S004 |
Date Received | 06/09/1986 |
Decision Date | 11/14/1986 |
Withdrawal Date
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03/22/2007 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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