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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K052525
Device Name CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
Applicant
DFI Co., Ltd.
2815 Mcgaw Ave.
Irvine,  CA  92614
Applicant Contact ASAD R ZAIDI
Correspondent
DFI Co., Ltd.
2815 Mcgaw Ave.
Irvine,  CA  92614
Correspondent Contact ASAD R ZAIDI
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMA   JMT   LJX  
Date Received09/14/2005
Decision Date 03/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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