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 PHARMADX 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 | S001 |
Date Received | 12/07/2011 |
Decision Date | 02/01/2012 |
Withdrawal Date
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01/24/2018 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN UPDATE OF THE SOFTWARE DOCUMENTATION FOR DAKOLINK SOFTWARE VERSION 3.0 TO DAKOLINK VERSION 3.1.1. |
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