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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-HBc IgM and PreciControl Anti-HBc IgM
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP110022
Supplement NumberS022
Date Received07/06/2017
Decision Date12/21/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for migration of the Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM to the cobas e 801 immunoassay analyzer.
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