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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 K871586
Device Name GLUCOCHEK S.C. WITH AUDIO OPTION
Applicant
Larken Industries, Inc.
8275 Melrose
Lenexa,  KS  66214
Applicant Contact DANIEL BOONE
Correspondent
Larken Industries, Inc.
8275 Melrose
Lenexa,  KS  66214
Correspondent Contact DANIEL BOONE
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/23/1987
Decision Date 09/16/1987
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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