• 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 alkaline picrate, colorimetry, creatinine
Regulation Description Creatinine test system.
Product CodeCGX
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 4
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 33
High test results 14
Low test results 9
No Known Device Problem 2
False negative result 1
Suction issue 1
Contamination of device ingredient or reagent 1
Total Device Problems 61

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Mar-15-2013
2 Beckman Coulter Inc. II Sep-09-2010
3 Horiba Instruments Inc II Feb-02-2016
4 Horiba Instruments, Inc dba Horiba Medical III Nov-14-2012
5 Pointe Scientific, Inc. III Sep-16-2015
6 Pointe Scientific, Inc. II Mar-09-2010
7 Roche Diagnostics Corp. II Oct-09-2008
8 Siemens Healthcare Diagnostics, Inc. II Jun-26-2015
9 Siemens Healthcare Diagnostics, Inc. II Jan-15-2012

-
-