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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(R) HYBRITECH PSA ASSAY
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 NumberS016
Date Received10/18/1999
Decision Date02/24/2000
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of the access hybritech psa assay on the access immunoassay analyzer to other approved instrument platforms.
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