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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACCESS(R) HYBRITECH PSA ASSAY
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd m/s
w-110
brea, CA 92822
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 - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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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