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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 K033851
Device Name DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
Applicant
Hypoguard USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact BRUCE MACFARLANE
Correspondent
Hypoguard USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact BRUCE MACFARLANE
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Code
JIN  
Date Received12/11/2003
Decision Date 03/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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