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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 ACCESS IMMUNOASSAY SYSTEMS
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Namekit, test, prostate specific antigen
Regulation Number866.6010
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS019
Date Received12/20/2002
Decision Date03/03/2003
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the access hybritech psa assay to the unicel dxi 800 access immunoassay system.
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