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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 SYSTEMS
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namekit, test, prostate specific antigen
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS020
Date Received04/10/2006
Decision Date05/18/2006
Product Code
MTF[ Registered Establishments with MTF ]
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 psa reagent on the access immunoassay system.
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