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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.
 
DeviceHERCEPTEST
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
DAKO A/S
42 produktionsvej
glostrup DK-26-2600
PMA NumberP980018
Supplement NumberS010
Date Received04/21/2010
Decision Date10/20/2010
Product Code
MVC[ Registered Establishments with MVC ]
Docket Number 10M-0557
Notice Date 11/17/2010
Advisory Committee Pathology
Clinical Trials NCT01041404
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the herceptest kit. The device is indicated for in vitro diagnostic use. Herceptest is a semi-quantitative immunocytochemi-cal assay to determine her2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Herceptest is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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