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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device centrifuge, blood-bank for in vitro diagnostic use
Regulation Description Blood bank centrifuge for in vitro diagnostic use.
Product CodeKSO
Regulation Number 864.9275
Device Class 1


Premarket Reviews
ManufacturerDecision
GAMMA
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1

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