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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 CALCHECK
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 NumberS009
Date Received06/09/2008
Decision Date07/09/2008
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 INTRODUCTION OF THE ELECSYS ANTI-HBS CALCHECK FOR USE WITH THE ELECSYS ANTI-HBS TEST SYSTEM. THE ELECSYS ANTI-HBS CALCHECK IS USED FOR THE VERIFICATION OF THE CALIBRATION ESTABLISHED WITH THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS. THE ELECSYS ANTI-HBS CALCHECK IS NOT A CALIBRATOR.
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