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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device colorimetric method, cpk or isoenzymes
Product CodeJHY
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 2 2
2016 4 4
2017 11 11
2018 5 5
2019 2 2
2020 2 2
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 25 25
Low Test Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Or Inadequate Test Results 2 2
Complete Blockage 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 8 8
No Clinical Signs, Symptoms or Conditions 4 4
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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