• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device activated whole blood clotting time
Regulation Description Activated whole blood clotting time tests.
Product CodeJBP
Regulation Number 864.7140
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 4
I-STAT
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 7
High test results 6
No Known Device Problem 2
Overheating of device or device component 1
Charging issue 1
Total Device Problems 17

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Feb-16-2011
2 Abbott Point Of Care Inc. II Nov-17-2010
3 Abbott Point of Care Inc. II Feb-23-2010
4 International Technidyne Corp. II Aug-21-2009

-
-