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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.
 
Trade NameACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namekit, test, prostate specific antigen
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS032
Date Received01/23/2013
Decision Date03/26/2013
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Pproval for 1) the change in polypropylene resin used for the reaction 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 in polypropylene 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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