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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 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 NumberS018
Date Received10/25/2012
Decision Date11/19/2012
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 information to the manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification. ).
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