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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 K952971
Device Name DIA SCREEN REAGENT STRIPS
Applicant
Genesis Labs, Inc.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact JOHN MURRAY
Correspondent
Genesis Labs, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact JOHN MURRAY
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
JIN   JIR  
Date Received06/27/1995
Decision Date 08/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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