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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 K863223
Device Name DIMENSION-WBG
Applicant
Dimension Diagnostics
361 Windsor Pl.
St. Peters,  MO  63376
Applicant Contact CLYDE E HAM
Correspondent
Dimension Diagnostics
361 Windsor Pl.
St. Peters,  MO  63376
Correspondent Contact CLYDE E HAM
Regulation Number862.1345
Classification Product Code
CGA  
Date Received08/21/1986
Decision Date 03/10/1987
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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