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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device control, plasma, abnormal
Regulation Description Multipurpose system for in vitro coagulation studies.
Product CodeGGC
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 2

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