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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 HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM
Classification Namep2psa
Generic Namep2psa
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, MN 55318
PMA NumberP090026
Supplement NumberS011
Date Received06/12/2014
Decision Date07/07/2014
Product Code
OYA[ Registered Establishments with OYA ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the quality control prefill and postfill reagent pack procedures.
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