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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
190-4038149-3/1/1 19-Sep-2011 57AH99 3008927987 Commonwealth Serum Laboratories Australia
 
112-8429592-4/1/1 26-Sep-2011 57CH25 1000522100 GlaxoSmithKline LLC United States
 
112-3382817-2/1/1 01-Sep-2011 57UH02 2432235 Siemens Healthcare Diagnostics United States
 
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