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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device Autopheresis-C Plasmapheresis System
Classification Nameseparator, automated, blood cell, diagnostic
Generic Nameautomated blood cell separator -filtration
Regulation Number864.9245
Applicant
Baxter Healthcare Corporation
route 120 & wilson road
Round Lake , IL 60073 
  
PMA NumberBP850001
Date Received04/01/1985
Decision Date03/24/1986
Decision Approved
Product Code
GKT[ Registered Establishments with GKT ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S025 S026 S027 S028 
S029 S030 S031 S032 S034 
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