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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceELECSYS HBEAG ON MODULAR ANALYTICS E170
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
9115 HAGUE RD
INDIANAPOLIS, IN 46250
PMA NumberP130015
Supplement NumberS002
Date Received10/16/2014
Decision Date11/26/2014
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
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