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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 K862984
Device Name UNIDEX GLUCOSE TEST STRIP
Applicant
Unidex, Inc.
4038-B 128th Ave., SE
Suite 170
Bellevue,  WA  98006
Applicant Contact MILLER, JR.
Correspondent
Unidex, Inc.
4038-B 128th Ave., SE
Suite 170
Bellevue,  WA  98006
Correspondent Contact MILLER, JR.
Regulation Number862.1345
Classification Product Code
CGA  
Date Received08/07/1986
Decision Date 11/05/1986
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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