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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.
Classification Nameanalyzer, chemistry (photometric, discrete), for clinical use
Generic Nameimmunochemistry analyzer
Regulation Number862.2160
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.