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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NameHER2 IQFISH PHARMDX
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameerbb2 gene amplification kit
ApplicantDAKO DENMARK A/S
PMA NumberP040005
Supplement NumberS007
Date Received12/14/2011
Decision Date12/05/2012
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the formulation of the her2 fish pharmdx kit. The device, as modified, will be marketed under the trade name her2 iqfish pharmdx.
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