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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceACCESS AFP IMMUNOASSAY SYSTEM
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP980041
Date Received10/16/1998
Decision Date02/08/1999
Product Code LOK 
Docket Number 99M-0793
Notice Date 04/08/1999
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Access(R) AFP Reagents on the Access(R) Immunoassay Analyzer. The Access(R) AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access(R) Immunoassay System for the quantitative determination fo alpha-fetoprotein (AFP) in: 1)Human seru, as an aid in management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S023  S032 S033 S014 S015 S005 S006 S027 S028 S029 S007 
S009 S001 S002 S004 S012 S010 S035 S036 S017 S021 S022 S024 
S026 S018 S030 S031 S016 S003 S008 S011 S013 S037 S034 S025 
S044 S045 S043 S048 S040 S039 S049 S047 S041 S046 S050 
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