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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K090330
Device Name DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Applicant Contact ROSE T MARINELLI
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Correspondent Contact ROSE T MARINELLI
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Code
JIT  
Date Received02/10/2009
Decision Date 05/22/2009
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
Recalls CDRH Recalls
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