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


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
FISHER
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 2
Low test results 2
Incorrect or inadequate result 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 1 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Dade Behring, Inc. II Jan-28-2009
2 Siemens Healthcare Diagnostics II Mar-21-2012
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Siemens Healthcare Diagnostics, Inc. II Nov-10-2010

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