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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 HYBRITECT FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd m/s
w-110
brea, CA 92822
PMA NumberP970038
Supplement NumberS011
Date Received12/19/2007
Decision Date03/06/2008
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A REFORMULATED WASH BUFFER, WASH BUFFER II ON THE ACCESS IMMUNOASSAY SYSTEMS.
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