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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACCESS IMMUNOASSAY SYSTEMS
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namechemiluminescent immunoassay for in vitro diagnostic quantitation of afp in maternal and amniotic fluid
ApplicantBECKMAN COULTER, INC.
PMA NumberP980041
Supplement NumberS013
Date Received09/27/2010
Decision Date07/01/2011
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications made to the access, synchron and unicel families of instrumentation platforms: 1) modification of the occlusion bracket on the access and unicel instruments, b) revision of the unicel system software, and c) redesign of the sample probe tube assembly, and d) new information regarding potential interferents of afp measurement due to the presence of immunosuppressant drugs prescribed to pregnant women.
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