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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 75-Chemistry


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7307474-3/1/2 26-Aug-2009 75CHH 1000123985 Cholestech Corp United States
 
112-7156148-5/2/1 28-Aug-2009 75JIR 1000380439 Bayer Diagnostics Uk Limited United Kingdom
 
112-7156148-5/1/1 28-Aug-2009 75JJW 3002806559 Roche Diagnostics Gmbh Germany
 
112-7168542-5/1/1 28-Aug-2009 75JRO 3006526541 Sulis International Ltd United Kingdom
 
XXX-0164178-7/3/1 20-Aug-2009 75JRS 3007637478 Harbin Tiandiren Medical Science and Technology Co., Ltd China
 
112-8403000-7/1/1 17-Aug-2009 75NBW 3007705687 Exim Labs China
 
BHC-5003124-2/8/1 21-Aug-2009 75NBW 3002803444 Abbott Diabetes Care, Inc. United States
 
BHC-5003124-2/8/2 21-Aug-2009 75NBW 3002803444 Abbott Diabetes Care, Inc. United States
 
BHC-5003124-2/14/1 21-Aug-2009 75NBW 1000113657 Nipro Diagnostics, Inc. United States
 
112-6601763-4/1/1 03-Aug-2009 75OIB 3006272261 Eurofins Medinet Netherlands
 
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