• 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 calibrator, primary
Regulation Description Calibrator.
Product CodeJIS
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 6
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 5
  1.  K770072  BIO TROL-T TRIOLEIN SOLUTIONS
  2.  K810963  BIO SET TM SUBSTRATE CALIBRATORS
  3.  K832251  PRECISET CHOLESTEROL HIGH PERFORM
  4.  K844581  80 MG/DL GLUCOSE CONTROL
  5.  K870379  ISE COMPENSATION SERA
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 6
DOW
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 4
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Calibration issue 2
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostic International, Ltd. II Jul-24-2008
2 Beckman Coulter Inc. II Dec-22-2012
3 Beckman Coulter Inc. II Jun-21-2011
4 Siemens Healthcare Diagnostics, Inc III Aug-14-2013
5 Siemens Healthcare Diagnostics, Inc II Apr-15-2013
6 Siemens Healthcare Diagnostics, Inc. III Jan-29-2013

-
-