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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 K062152
Device Name CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
Applicant
Dade Behring, Inc.
500 Gbc Dr.,
M/S 514, P.O. Box 6101
Newark,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
Dade Behring, Inc.
500 Gbc Dr.,
M/S 514, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1150
Classification Product Code
JIT  
Date Received07/27/2006
Decision Date 08/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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