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 | HER2 CISH PHARMDX KIT |
Generic Name | chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer |
Applicant | DAKO DENMARK A/S 42 produktionsvej dk-2600 glostrup DK-26-2600 |
PMA Number | P100024 |
Supplement Number | S007 |
Date Received | 08/13/2015 |
Decision Date | 09/10/2015 |
Withdrawal Date
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01/24/2018 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED. |
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