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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 XXX-0047296-0/1/1


Manufacturer FEI3000138259
Manufacturer NameDenka Seiken Co Ltd  
Manufacturer Address line 142 Nihonbashi Kayaba Cho 3chome  
Manufacturer Address line 2  
Manufacturer's CityTokyo  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code83LIB  
FDA Product DescriptionDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC  
Refusal Date26-Aug-2002  
FDA DistrictNYK-DO  
Entry/doc/line/sfx XXX-0047296-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
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