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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
510(k) Number K943008
Device Name BIOSCAN REAGENT STRIPS
Applicant
Genesis Labs, Inc.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact MARTHA CORNELL
Correspondent
Genesis Labs, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact MARTHA CORNELL
Regulation Number862.1115
Classification Product Code
JJB  
Subsequent Product Codes
CEN   JIL   JIN   JMT  
Date Received06/24/1994
Decision Date 08/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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