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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 K854335
Device Name GLUCOSE REAGENT SET (GOD/TRINDER)
Applicant
Sterling Diagnostics, Inc.
34210 Dequindre Rd.
Sterling Heights,  MI  48077
Applicant Contact DAVID L CALLENDER
Correspondent
Sterling Diagnostics, Inc.
34210 Dequindre Rd.
Sterling Heights,  MI  48077
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1345
Classification Product Code
CGA  
Date Received10/28/1985
Decision Date 11/22/1985
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
Recalls CDRH Recalls
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