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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device strip, test, reagent, residuals for dialysate, disinfectant
Regulation Description Water purification system for hemodialysis.
Product CodeMSY
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 31
Water treatment 31
Device Issue 30
Unknown (for use when the device problem is not known) 1
Residue after decontamination 1
False reading from device non-compliance 1
Total Device Problems 95

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