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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Classification Nametest, volatile organic compounds breath analysis
Generic Nametest, volatile organic compounds breath analysis
Menssana Research, Inc.
1 horizon rd.
suite 1415
fort lee, NJ 07024
HDE NumberH030004
Date Received08/18/2003
Decision Date02/24/2004
Product Code
Docket Number 04M-0084
Notice Date 02/24/2004
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2