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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.
 
DeviceHER2 IQFISH PHARMDX
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 NumberS012
Date Received01/08/2016
Decision Date01/29/2016
Product Code MVD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285. PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE: HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.
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