• 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 instrumentation, high pressure liquid chromatography
Regulation Description High pressure liquid chromatography system for clinical use.
Product CodeLDM
Regulation Number 862.2260
Device Class 1


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 3
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Incorrect or inadequate test results 1
Total Device Problems 1

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 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


-
-