• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Actions by FDA as Recorded in OASIS

for 81-Hematology


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-9616885-3/2/1 18-Oct-2011 81GKR 3003044483 HemoCue AB Sweden
 
201-1960145-7/1/1 20-Oct-2011 81KSF 3005119000 Ge Health Care Sweden
 
112-9903351-8/1/1 18-Oct-2011 81MVU 3008199673 Twistdx Limited United Kingdom
 
112-9259085-2/1/1 18-Oct-2011 81OOX 1220649 Bionostics, Inc. United States
 
-
-