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. |
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Device | HERCEP TEST |
Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
Applicant | Agilent Technologies Singapore (International) Pte Ltd. No. 1 Yishun Avenue 7 Singapore 76892 |
PMA Number | P980018 |
Supplement Number | S019 |
Date Received | 04/27/2015 |
Decision Date | 05/21/2015 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFY THE IN PROCESS QUALITY CONTROL (IPC) TEST TO VERIFY THE PERFORMANCE OF BULK REAGENTS (INTERMEDIATES) DAB+ BUFFERED SUBSTRATE AND DAB+ CHROMOGEN. |
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