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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameABBOTT ER-ICA MONOCLONAL
Classification Namekit, assay, estrogen receptor
Generic Namemonoclonal
Regulation Number864.1860
ApplicantABBOTT LABORATORIES
PMA NumberP880026
Date Received04/04/1988
Decision Date09/30/1988
Withdrawal Date 09/12/2007
Product Code
LPJ
Docket Number 88M-0352
Notice Date 12/02/1988
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
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