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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 K923587
Device Name GLUCOSE TEST SYSTEM
Applicant
Polymer Technology Corp.
1595 NW Gilman Blvd.
Suite 17
Issaquah,  WA  98027
Applicant Contact TERRY G KELLEY
Correspondent
Polymer Technology Corp.
1595 NW Gilman Blvd.
Suite 17
Issaquah,  WA  98027
Correspondent Contact TERRY G KELLEY
Regulation Number862.1345
Classification Product Code
CGA  
Date Received06/23/1992
Decision Date 12/28/1992
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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