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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameMESOMARK
Classification Namecancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Generic Namecancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Applicant
Fujirebio Diagnostics, Inc.
201 great valley pkwy.
malvern, PA 19355-1307
HDE NumberH060004
Supplement NumberS001
Date Received01/31/2007
Decision Date04/20/2007
Product Code
OAW[ Registered Establishments with OAW ]
Advisory Committee Immunology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the product labeling and patient information brochure.
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