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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
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP980041
Supplement NumberS034
Date Received06/10/2016
Decision Date11/18/2016
Product Code LOK 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing process change to the Working Strength Particles Batch Size process, which is used in preparation of the paramagnetic particles (PMP) for use in the Access AFP Reagent.
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