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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 K855178
Device Name DIATRON BLOOD GLUCOSE METER
Applicant
Dextron, Inc.
214 # Main St., #202, P.O.
Box 510
Natick,  MA  01760
Applicant Contact RICHARD VANDERSLICE
Correspondent
Dextron, Inc.
214 # Main St., #202, P.O.
Box 510
Natick,  MA  01760
Correspondent Contact RICHARD VANDERSLICE
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/26/1985
Decision Date 08/04/1986
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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