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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, quality control for blood banking reagents
Regulation Description Quality control kit for blood banking reagents.
Product CodeKSF
Regulation Number 864.9650
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 10
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 21
MICRO TYPING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
RED CROSS
  SUBSTANTIALLY EQUIVALENT 2

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