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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acid, uric, uricase (colorimetric)
Regulation Description Uric acid test system.
Product CodeKNK
Regulation Number 862.1775
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 5
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malfunction 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jan-28-2015
2 Horiba Instruments Inc II Feb-02-2016
3 Ortho-Clinical Diagnostics II Nov-15-2013
4 Pointe Scientific, Inc. II Mar-02-2010
5 Roche Diagnostics Operations, Inc. II Jun-27-2015
6 Siemens Healthcare Diagnostics, Inc. II May-11-2016

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