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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 Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS034
Date Received04/12/2013
Decision Date08/20/2013
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the labeling of unicel dx1 instructions for use, operator's guide, reference manual and onboard system help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance thesafety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warningto caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the unicel dxl 800/600 immunoassay systems and unicel dxc 880i/860i/680i/ 660i synchron access integrated clinical systems.
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