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 | S002 |
Date Received | 07/11/2012 |
Decision Date | 07/31/2012 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement MANUFACTURING PROCESS OF PNA OLIGOMERS IN THE DEVICE. |
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