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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lipase-esterase, enzymatic, photometric, lipase
Regulation Description Lipase test system.
Product CodeCHI
Regulation Number 862.1465
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 2
No Information 2
Device ingredient or reagent issue 1
No Known Device Problem 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Sep-18-2007
2 Abbott Laboratories, Inc II Oct-28-2014
3 Genzyme Corporation III Aug-22-2008
4 Ortho-Clinical Diagnostics II Nov-15-2013
5 Siemens Healthcare Diagnostics, Inc. II Apr-20-2015
6 Siemens Healthcare Diagnostics, Inc. II Dec-10-2010

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