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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 NameARCHITECT TOTAL PSA ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameimmunochemistry analyzer
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS017
Date Received06/13/2008
Decision Date05/29/2009
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for migration of the architect total psa assay to a new architect i system family member, the architect i1000sr.
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