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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Mechanical issue 1
Device Issue 1
Low test results 1
No Known Device Problem 1
Osseointegration issue 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtest Holdings, Inc. III Jun-29-2017

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