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 | SPOT-LIGHT HER2 CISH KIT |
Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
Applicant | INVITROGEN CORPORATION 3175 STALEY RD. GRAND ISLAND, NY 14072 |
PMA Number | P050040 |
Supplement Number | S003 |
Date Received | 06/01/2012 |
Decision Date | 07/06/2012 |
Withdrawal Date
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01/07/2015 |
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 | No |
Approval Order Statement EXTENSION OF THE EXPIRATION DATE FOR A SINGLE LOT OF HER-2 SPT DNA TEMPLATE (LOT 63013). |
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