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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.
 
DeviceTANDEM-MP PSA IMMUNOENZYMETRIC ASSAY
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP850048
Supplement NumberS014
Date Received05/19/1999
Decision Date06/16/1999
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Dr., Chaska, MN 55318.
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