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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hexokinase, glucose
Regulation Description Glucose test system.
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 4
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 3
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 6
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 17
High test results 15
Incorrect or inadequate test results 2
Total Device Problems 34

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 0 2 0 0 0 0 1 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Sep-21-2008
2 Horiba Instruments Inc II Feb-02-2016
3 JAS Diagnostics Inc. II Dec-18-2014
4 Mindray DS USA, Inc. d.b.a. Mindray North America II Mar-22-2013
5 Pointe Scientific, Inc. I Nov-04-2009
6 Pointe Scientific, Inc. II Oct-31-2008

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