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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorometric method, cpk or isoenzymes
Product CodeJHX
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 7 7
2020 3 3
2021 10 10
2022 2 2
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 10 10
High Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 2 2
High Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 1 1

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