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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device strip, dialysate, ph, bicarbonate, glucose, acid, indicator
Regulation Description Hemodialysis system and accessories.
Definition DEVICE PROVIDES SEMIQUANTITATIVE INDICATIONS OF PH, BICARBONATE IONS, AND GLUCOSE IN THE FINAL BICARBONATE DIALYSATE.
Product CodeNTZ
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1

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