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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 fluorometric method, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeJHX
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High Test Results 11
Incorrect, Inadequate or Imprecise Result or Readings 5
Incorrect Or Inadequate Test Results 4
Low Test Results 3
High Readings 2
False Positive Result 2
Use of Device Problem 1
Computer Software Problem 1
Total Device Problems 29

Recalls
Manufacturer Recall Class Date Posted
1 Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc II Sep-17-2018
2 Siemens Healthcare Diagnostics Inc II Aug-11-2016
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Tosoh Bioscience Inc II Jun-05-2018

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