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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 57-Bio & Licensed In-Vivo & In-Vitro Diag


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2649615-8/1/1 10-Aug-2006 57KY01 3005838155 Sabina Zilberman United Kingdom
 
FR1-0011525-7/1/1 01-Aug-2006 57YH02 3003279193 Amsino Medical Instrument Co Ltd China
 
FR1-0011543-0/1/1 23-Aug-2006 57YH02 3003279193 Amsino Medical Instrument Co Ltd China
 
814-0148748-3/1/1 09-Aug-2006 57YJ99 3005772148 Biofocus (A Galapagos Company) Netherlands
 
112-2498552-5/1/1 02-Aug-2006 57YY99 3003206361 Savyon Diagnostics Ltd. Israel
 
AEK-7119355-7/1/1 07-Aug-2006 57YY99 3005465540 Beijing Gingko Group China
 
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