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 | ELECSYS ANTI-HBS TEST SYSTEM |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P010054 |
Supplement Number | S007 |
Date Received | 09/04/2007 |
Decision Date | 11/13/2008 |
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 |
Approval Order Statement APPROVAL FOR THE EXTENSION OF THE ELECSYS HBSAG TEST SYSTEM AND THE ELECSYS ANTI-HBS TEST SYSTEM ONTO THE UPDATED MODEL OF THE ELECSYS 2010 ANALYZER, KNOWN AS THE COBAS E 411 ANALYZER. |
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