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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.
 
DeviceDAKOCYTOMATION HER2 FISH PHARMDX KIT
Generic NameSystem, Test, Her-2/Neu, Nucleic Acid Or Serum
Regulation Number864.1890
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 768923
PMA NumberP040005
Supplement NumberS013
Date Received03/16/2016
Decision Date04/12/2016
Product Code MVD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the DNA propagation and purification processes.
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