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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 K921825
Device Name QUICK-CHECK II REAGENT STRIP
Applicant
Diagnostic Solutions, Inc.
27071 Cabot Rd.
Suite 101
Laguna Hills,  CA  92653
Applicant Contact CHEN, PH.D.
Correspondent
Diagnostic Solutions, Inc.
27071 Cabot Rd.
Suite 101
Laguna Hills,  CA  92653
Correspondent Contact CHEN, PH.D.
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/16/1992
Decision Date 08/18/1992
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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