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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 NameABBOTT ARCHITECT TOTAL PSA
Classification Nameanalyzer, chemistry (photometric, discrete), for clinical use
Generic Nameimmunochemistry analyzer
Regulation Number862.2160
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS012
Date Received08/30/2004
Decision Date09/10/2004
Product Code
JJE[ Registered Establishments with JJE ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the method for addition of mak-33 to the anti-psa coated microparticles component of the reagent pack for the abbott architect total psa.
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