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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 NumberS004
Date Received06/20/2005
Decision Date07/13/2005
Product Code MVC 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE SUPPLIER OF THE REAGENT FOR IMMUNIZATION OF RABBITS AND SUBSEQUENT CHANGES IN MANUFACTURING PROCESS AND QUALITY CONTROL PROCEDURES.
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