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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameENZYMUN-TEST{R} AFP
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameenzymun-linked immunosorbent afp
Regulation Number866.6010
ApplicantBOEHRINGER MANNHEIM CORP.
PMA NumberP860044
Supplement NumberS003
Date Received12/24/1990
Decision Date09/03/1991
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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