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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K850257
Device Name BCS GLUCOSE COLORIMETRIC TEST
Applicant
Bioclinical Systems, Inc.
5977 Southwest Ave.
St.Louis,  MO  63139
Applicant Contact BRUCE F WATKINS
Correspondent
Bioclinical Systems, Inc.
5977 Southwest Ave.
St.Louis,  MO  63139
Correspondent Contact BRUCE F WATKINS
Regulation Number862.1345
Classification Product Code
CGA  
Date Received01/22/1985
Decision Date 03/05/1985
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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