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U.S. Department of Health and Human Services

Import Refusal Report

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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
112-5108456-6/1/1 07-Jan-2011 81GIO 3004725755 Adnagen Ag Germany
 
112-8913045-5/2/1 31-Jan-2011 81GIO 3003038758 Hemosense Inc United States
 
112-8913045-5/1/1 31-Jan-2011 81JIO 1000125596 Alere San Diego, Inc. United States
 
112-0239539-3/1/2 04-Jan-2011 81KSJ 3003275790 Qualpro Diagnostics India
 
K51-0070922-6/1/1 19-Jan-2011 81LLG 3002427037 Haemonetics Sa Switzerland
 
112-7878740-6/1/1 03-Jan-2011 81MTK 3006039599 Globalemed Sa Pty Ltd South Africa
 
112-0239539-3/1/1 04-Jan-2011 81MTN 3003275790 Qualpro Diagnostics India
 
112-0239539-3/1/4 04-Jan-2011 81MTN 3003275790 Qualpro Diagnostics India
 
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