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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 REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification Namep2psa
Generic Namep2psa
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, MN 55318
PMA NumberP090026
Supplement NumberS010
Date Received12/17/2013
Decision Date05/01/2014
Product Code
OYA[ Registered Establishments with OYA ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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