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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 ANTI-HBS IMMUNOASSAY
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP010054
Supplement NumberS022
Date Received04/09/2013
Decision Date03/21/2014
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 THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION.
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