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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.
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
PMA NumberP980041
Supplement NumberS022
Date Received01/23/2013
Decision Date03/25/2013
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the change in polypropylene resin used for thereaction vessel container material that is used as the container for the reaction in the determination of results for access afp reagents, access hybritech psa reagents, access hybritech free psa reagents and access hybritech p2psa reagents; 2) the change inpolypropylene resin used for the reagent pack container for access hybritech p2psa reagents and 3) the change in polypropylene resin used for the bottle cap for access afp sample diluent and access hybritech psa sample diluent and access substrate for access afp, access hybritech psa, access hybritech free psa and access hybritech p2psa.