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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-0206478-8/2/1

Manufacturer FEI3008097535
Manufacturer NameClindiag Systems Co Ltd  
Manufacturer Address line 1Dongshan Ind Zone Jiangning District  
Manufacturer Address line 2  
Manufacturer's CityNanjing  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code75JJL  
Importer's Product DescriptionHEMATOLOGY ANALYZER REG# 3004185838 / 9083913  
Refusal Date17-Sep-2010  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BTU-0206478-8/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).