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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 FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS
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 NumberS008
Date Received04/10/2006
Decision Date05/18/2006
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the access psa reagents for use on the unicel dxc 600i synchron access clinical system. The device, as modified, will be marketed under the trade name access free psa reagent on the access immunoassay system.
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