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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa test kit
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP930027
Date Received08/10/1993
Decision Date09/15/1995
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 96M-0217
Notice Date 09/12/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the coat-a-count psa irma.
Approval Order Approval Order
Supplements: S001 S003 S004 S005 S006 S007 S008 S010 S011 
S012 S013 S014 S015 
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