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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 REAGENT 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 NumberS017
Date Received10/25/2012
Decision Date11/19/2012
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of information to the manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification. ).
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