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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 IMMUNOASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namekit, test, prostate specific antigen
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS023
Date Received12/19/2007
Decision Date02/26/2008
Product Code
MTF[ Registered Establishments with MTF ]
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 reformulated wash buffer, wash buffer ii, on the access immunoassay systems.
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