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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 NameTANDEM-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 o
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP850048
Supplement NumberS011
Date Received06/14/1995
Decision Date11/06/1995
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - other
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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