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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.
 
DeviceABBOTT REALTIME HBV
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP080026
Supplement NumberS005
Date Received12/26/2012
Decision Date02/07/2013
Reclassified Date10/20/2025
Product Code MKT 
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  
CHANGE TO THE EXISTING LABEL PRINT AND INSPECTION EQUIPMENT WITH 2 NEW LABEL PRINTERS, NEW LABEL PRINTING SOFTWARE, AND A NEW LABEL INSPECTION SYSTEM THAT IS USED TO PRINT AND INSPECT LABELS FOR ALL MANUFACTURED PARTS AT ABBOTT MOLECULAR INC. IN DES PLAINES, ILLINOIS.
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