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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device indicator method, protein or albumin (urinary, non-quant.)
Product CodeJIR
Regulation Number 862.1645
Device Class 1


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHY.IO LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 4 4
2016 5 5
2017 2 2
2019 1 1
2020 2 2
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5
Incorrect Or Inadequate Test Results 3 3
Low Test Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Positive Result 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Non Reproducible Results 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1
Patient Problem/Medical Problem 1 1

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