Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device separator, automated, blood cell and plasma, therapeutic
Product CodeLKN
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
CARIDIANBCT, INC.
  SUBSTANTIALLY EQUIVALENT 2
FENWAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI USA LLC
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO BCT, INC..
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Caridian BCT, Incorporated II Nov-16-2011
2 Caridian BCT, Incorporated II Jun-28-2011
3 CaridianBCT, Inc. II May-30-2012
4 CaridianBCT, Inc. II May-09-2012
5 Fenwal Inc II Mar-15-2023
6 Fenwal Inc II Apr-02-2021
7 Fenwal Inc II Jun-08-2013
8 Fresenius Kabi, LLC II May-16-2011
9 Fresenius Kabi, LLC I Dec-16-2010
-
-