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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K870708
Device Name GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
Applicant
Kyoto Daiichi Kagaku Co., Ltd.
57 Nishi Aketa Cho
Higashi Kujo Minami Ku
Kyoto, 601,  JP
Applicant Contact SHIGEKI YAMADA
Correspondent
Kyoto Daiichi Kagaku Co., Ltd.
57 Nishi Aketa Cho
Higashi Kujo Minami Ku
Kyoto, 601,  JP
Correspondent Contact SHIGEKI YAMADA
Regulation Number862.1345
Classification Product Code
LFR  
Date Received02/20/1987
Decision Date 02/02/1988
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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