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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
Classification Namehepatitis viral b dna detection
Generic Namehepatitis viral b dna detection
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP080026
Supplement NumberS005
Date Received12/26/2012
Decision Date02/07/2013
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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