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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Namealpha-fetoprotein (afp) test kit for testicular ca
Regulation Number866.6010
PMA NumberP840035
Supplement NumberS007
Date Received05/06/1988
Decision Date06/03/1988
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No