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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.
 
DeviceACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd m/s
w-110
brea, CA 92822
PMA NumberP980041
Supplement NumberS005
Date Received07/01/2004
Decision Date07/15/2004
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the manufacturing process to the reagent pack intermediate components for the access afp reagents on the access immunoassay analyzer.
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