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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MVD PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
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PMA
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PATHVYSION HER-2 DNA PROBE KIT ABBOTT MOLECULAR, INC. P980024 S012 12/20/2013
THE PATH VYSION HER-2 DNA PRODE KIT ABBOTT MOLECULAR, INC. P980024 S011 11/27/2013
HER2 IQFISH PHARMDX Agilent Technologies Singapore P040005 S010 08/28/2013
HER2 FISH PHARMADX KIT Agilent Technologies Singapore P040005 S009 02/22/2013
PATHVYSION HER-2 DNA PROBE KIT ABBOTT MOLECULAR, INC. P980024 S010 02/10/2013
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