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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device media, potentiating for in vitro diagnostic use
Regulation Description Potentiating media for in vitro diagnostic use.
Product CodeKSG
Regulation Number 864.9600
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 8
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 5
MICRO TYPING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PFIZER
  SUBSTANTIALLY EQUIVALENT 1

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