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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 UPS-9532438-8/1/1

Manufacturer FEI3005445066
Manufacturer NameArtron Bioresearch  
Manufacturer Address line 13938 N Fraserway  
Manufacturer Address line 2  
Manufacturer's CityBurnabyburnaby  
Manufacturer Province/StateBRITISH COLUMBIA  
Manufacturer Country/AreaCanada  
Product Code75LCX  
Importer's Product DescriptionHCG PREGNANCY TEST  
Refusal Date30-Sep-2010  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-9532438-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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