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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.
 
DeviceMIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
Abbott Laboratories
100 abbott park rd.
ap5n-2 dept 09vb
abbott park, IL 60064-6070
PMA NumberP980007
Supplement NumberS009
Date Received05/21/2008
Decision Date05/28/2009
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for migration of the architect free psa assay to a newarchitect i system family member, the architect i1000sr.
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