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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colorimetry, acetaminophen
Product CodeLDP
Regulation Number 862.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
SEKISUI DIAGNOSTICS P.E.I. INC.
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI DIAGNOSTICS PEI INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5

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