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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 NameBAYER IMMUNO 1 SYSTEM
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate specific antigen assay (psa)
Regulation Number866.6010
ApplicantBAYER CORP.
PMA NumberP950021
Supplement NumberS001
Date Received12/22/1998
Decision Date06/25/1999
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 99M-2748
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the bayer immuno 1(tm) psa assay. This device is indicated for the measurement of serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
Approval Order Approval Order
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