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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 HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic Namep2psa
ApplicantBECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, MN 55318
PMA NumberP090026
Supplement NumberS010
Date Received12/17/2013
Decision Date05/01/2014
Product Code OYA 
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.
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