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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
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 NumberS026
Date Received09/26/2013
Decision Date10/17/2013
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.
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