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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plasma, coagulation control
Regulation Description Multipurpose system for in vitro coagulation studies.
Product CodeGGN
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 5
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 7
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 3
FISHER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 8
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 12
No Known Device Problem 4
Total Device Problems 16

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

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Feb-16-2012
2 Instrumentation Laboratory Co. II Dec-16-2013
3 International Technidyne Corp. II Aug-10-2010
4 International Technidyne Corporation II Jul-28-2010
5 International Technidyne Corporation II Jun-11-2010
6 TEM Systems Inc II Mar-09-2016

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