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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 SYSTEM
Classification Namep2psa
Generic Namep2psa
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, MN 55318
PMA NumberP090026
Supplement NumberS005
Date Received01/23/2013
Decision Date03/26/2013
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 
Pproval for 1) the change in polypropylene resin used for thereaction vessel container material that is used as the container for the reaction in the determination of results for access afp reagents, access hybritech psa reagents, access hybritech free psa reagents and access hybritech p2psa reagents; 2) the change inpolypropylene resin used for the reagent pack container for access hybritech p2psa reagents and 3) the change in polypropylene resin used for the bottle cap for access afp sample diluent and access hybritech psa sample diluent and access substrate for access afp, access hybritech psa, access hybritech free psa and access hybritech p2psa.
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