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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K022386
Device Name POCKETCHEM UA AUTION STICKS 10TA
Applicant
Arkray, Inc.
163 Cabot St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Arkray, Inc.
163 Cabot St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
JIP   KQO  
Date Received07/22/2002
Decision Date 09/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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