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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.
 
DeviceARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Dept 09v6, Bldg. Ap5-2
Abbott Park, IL 60064
PMA NumberP110029
Supplement NumberS026
Date Received06/30/2017
Decision Date09/27/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes in conditions for specimen centrifugation.
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