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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameTANDEM(R)-E AFP
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameafp for testicular cancer
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP840035
Supplement NumberS003
Date Received04/03/1986
Decision Date04/29/1988
Product Code
LOJ[ Registered Establishments with LOJ ]
Docket Number 88M-0184
Notice Date 06/27/1988
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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