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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 IMMUNOASSAY 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 NumberS016
Date Received03/15/2012
Decision Date04/13/2012
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new information to be added to the instructions for use, the operators guide and the reference manual, including the following: 1) add instructions to the weekly maintenance sections of these documents for the inspection of the liquid waste bottles; 2) clarify pack mixing instructions; 3) add troubleshooting steps; 4) change cautions into warnings; and 5) change notes into warnings.
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