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 | HERCEPTEST |
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 | S003 |
Date Received | 11/10/2004 |
Decision Date | 12/30/2005 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARK A/S, GLOSTRUP, DENMARK. |
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