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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device centrifuge, cell-washing, automated for immuno-hematology
Regulation Description Automated cell-washing centrifuge for immuno-hematology.
Product CodeKSN
Regulation Number 864.9285
Device Class 2


Premarket Reviews
ManufacturerDecision
HELMER INC.
  SUBSTANTIALLY EQUIVALENT 1


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