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 I1000 SYSTEM |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. DEPT 09V6, BLDG. AP5-2 ABBOTT PARK, IL 60064-6088 |
PMA Number | P110029 |
Supplement Number | S001 |
Date Received | 05/01/2012 |
Decision Date | 01/10/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MIGRATION OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAYS TO THE ARCHITECT I LOOOSR ANALYZER. |
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