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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.
 
DeviceHERCEP TEST
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantAgilent Technologies Singapore (International) Pte Ltd.
No. 1 Yishun Avenue 7
Singapore 76892
PMA NumberP980018
Supplement NumberS006
Date Received05/28/2008
Decision Date02/25/2010
Product Code MVC 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MARKET THE HERCEPTEST KIT FOR AUTOMATED LINK PLATFORMS AND THE CHANGES INVOLVED IN THE ASSAY PROCEDURE TO USE THE NEW INSTRUMENT, CHANGE IN THE QC PROCEDURE WITH REFERENCE TO CHROMOGEN, CHANGES IN THE CRITERIA REGARDING THE CONTROL TISSUE DURING QC AND CHANGES IN THE SPECIMEN PREPARATION.
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