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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-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC 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 NumberS011
Date Received06/14/1995
Decision Date11/06/1995
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR INCLUSION OF INFORMATION AND ATA ON PSA FORMS IN THE TANDEM PSA LABELING
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