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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, primary
Regulation Description Calibrator.
Product CodeJIS
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 6
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 5
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 6
DOW
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 4
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 0 1 1 1
Class III 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostic International, Ltd. II Jul-24-2008
2 Beckman Coulter Inc. II Dec-22-2012
3 Beckman Coulter Inc. II Jun-21-2011
4 Siemens Healthcare Diagnostics, Inc II Apr-15-2013
5 Siemens Healthcare Diagnostics, Inc. III Jan-29-2013

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