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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 Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Namekit, test, free prostate specific antigen (free psa)
ApplicantBECKMAN COULTER, INC.
PMA NumberP970038
Supplement NumberS015
Date Received12/23/2011
Decision Date02/17/2012
Product Code
MTG[ Registered Establishments with MTG ]
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 the change in polypropylene resin used for manufacturing of the reagent pack container.
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