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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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PMA Number P040005 Center Devices Decision Date To 01/24/2017
 
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DAKOCYTOMATION HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 05/03/2005
DAKOCYTOMATION HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 S013 04/12/2016
HER2 FISH PHARMADX KIT Agilent Technologies Singapore P040005 S009 02/22/2013
HER2 FISH PHARMADX KIT Agilent Technologies Singapore P040005 S006 06/08/2012
HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 S004 06/29/2010
HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 S005 10/20/2010
HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 S001 04/21/2006
HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 S002 02/13/2008
HER2 FISH PHARMDX KIT Agilent Technologies Singapore P040005 S008 07/31/2012
HER2 IQFISH pharmDx Agilent Technologies Singapore P040005 S014 04/12/2017
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