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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Namesystem, test, her-2/neu, nucleic acid or serum
42 produktionsvej
2600 glostrup DK-26-2600
PMA NumberP040005
Date Received01/29/2004
Decision Date05/03/2005
Product Code
MVD[ Registered Establishments with MVD ]
Docket Number 05M-0387
Notice Date 09/23/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the dakocytomation her2 fish pharmdx kit. The device is indicated for: the dakocytomation her2 fish pharmdx kit is a direct fluorescence in situ hybridization (fish) assay designed to quantitatively determine the her2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Her2 fish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. Results form the her2 fish pharmdx kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage ii, node positive breast cancer patients.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013