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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K060359
Device Name ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
Applicant
Denka Seiken Co., Ltd.
1-2-2, Minami Hon Cho
Gosen-Shi, Niigata,  JP 959-1695
Applicant Contact TOSHIMI MATSUNAGA
Correspondent
Denka Seiken Co., Ltd.
1-2-2, Minami Hon Cho
Gosen-Shi, Niigata,  JP 959-1695
Correspondent Contact TOSHIMI MATSUNAGA
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received02/13/2006
Decision Date 04/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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