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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceAFP MID-PREGNANCY REFERENCE PREPARATION
Generic NameCALIBRATOR FOR ALPHA-FETOPROTEIN IN MID-PREGNANCY MATERNAL SERUM
ApplicantCenters For Disease Control and Prevention
1600 Clifton Rd., Ms-C18
Atlanta, GA 30333
PMA NumberP820077
Date Received10/19/1982
Decision Date11/30/1984
Withdrawal Date06/12/2013
Product Code LTQ 
Docket Number 84M-0410
Notice Date 01/03/1985
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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