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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 supplement.
 
Device IMx Core-M Assay
Classification Namesystem, identification, hepatitis b antigen
Generic Nameidentification system for hepatitis b antigen
Applicant
Abbott Laboratories
abbott park buckley road and waukegan road
North Chicago , IL 60064 
  
PMA NumberBP900002
Supplement NumberS010
Date Received04/08/2004
Decision Date04/29/2004
Decision Approved
Product Code
KSJ[ Registered Establishments with KSJ ]
Advisory Committee Hematology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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