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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT ARCHITECT TOTAL PSA
Generic NameANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Regulation Number862.2160
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3500
PMA NumberP910007
Supplement NumberS012
Date Received08/30/2004
Decision Date09/10/2004
Product Code JJE 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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