| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | SPOT-LIGHT HER2 CISH KIT |
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| Classification Name | chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer |
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| Generic Name | in vitro diagnostic test kit for her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) tissue sections cho |
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| Applicant | LIFE TECHNOLOGIES, INC. |
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| PMA Number | P050040 |
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| Supplement Number | S003 |
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| Date Received | 06/19/2012 |
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| Decision Date | 07/06/2012 |
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| Product Code | |
| Advisory Committee |
Immunology |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Extension of the expiration date for a single lot of her-2 spt dna template (lot 63013). |
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