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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 NumberS025
Date Received01/12/2011
Decision Date02/04/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
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