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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzymatic esterase--oxidase, cholesterol
Regulation Description Cholesterol (total) test system.
Product CodeCHH
Regulation Number 862.1175
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 7
CHOLESTECH CORP.
  SUBSTANTIALLY EQUIVALENT 10
DOW
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 5
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 5
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 7
High test results 3
Total Device Problems 10

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 0 2 0 1 1 0 2 3
Class III 0 0 0 2 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego II Feb-06-2012
2 Beckman Coulter Inc. II Jun-08-2016
3 Beckman Coulter Inc. II Jan-28-2015
4 Diagnostic Chemicals, Ltd. III Dec-16-2010
5 Horiba Instruments Inc II Feb-02-2016
6 Ortho-Clinical Diagnostics II Nov-15-2013
7 Polymer Technology Systems, Inc. III Apr-02-2010
8 Polymer Technology Systems, Inc. II Mar-15-2010
9 Polymer Technology Systems, Inc. II Mar-01-2010
10 Roche Diagnostics Operations, Inc. II Jun-27-2015
11 Siemens Healthcare Diagnostics, Inc. II May-11-2016

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