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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCIBA CORNING ACS PSA IMMUNOASSAY
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
ApplicantBAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown, NY 10591
PMA NumberP920030
Date Received06/26/1992
Decision Date12/08/1998
Withdrawal Date 01/08/2003
Product Code LTJ 
Docket Number 94M-0349
Notice Date 10/27/1994
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S001 
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