• 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 electrode, ion based, enzymatic, creatinine
Regulation Description Creatinine test system.
Product CodeCGL
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 2
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 3
Electrical issue 1
False negative result 1
Total Device Problems 5

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 1 1 2 0 1 0 0 1 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 Nov-24-2010
2 Nova Biomedical Corporation II May-07-2009
3 Nova Biomedical Corporation II Feb-16-2008
4 Radiometer America Inc II Mar-18-2015
5 Radiometer America Inc II Feb-13-2012
6 Radiometer America Inc II Mar-05-2010

-
-