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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 ON TH ACCESS IMMNUNOASSAY SYSTEM
Generic NameP2psa
ApplicantBECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318
PMA NumberP090026
Supplement NumberS011
Date Received06/12/2014
Decision Date07/07/2014
Product Code OYA 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
MODIFICATION TO THE QUALITY CONTROL PREFILL AND POSTFILL REAGENT PACK PROCEDURES.
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