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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal BTU-0207547-9/1/1

Manufacturer FEI3004435367
Manufacturer NameShenzhen Emperor Electronic Technology Co Ltd  
Manufacturer Address line 12/f Bldg 7, Tianyan Nayou Industrial  
Manufacturer Address line 2  
Manufacturer's CityShenzhen  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code75JJG  
Importer's Product DescriptionCHEMISTRY ANALYZERS OWNER REG# 3004185838  
Refusal Date17-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BTU-0207547-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).