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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 HBsAg II
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics, Inc.
9115 Hague Rd.
Indianapolis, IN 46038
PMA NumberP160019
Supplement NumberS005
Date Received08/03/2017
Decision Date08/31/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Install an additional bead coating apparatus.
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