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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K143720
Device Name Dimension Vista MMB Assay
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact Kathleen Dray-Lyons
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact Kathleen Dray-Lyons
Regulation Number862.1215
Classification Product Code
JHY  
Subsequent Product Code
JJE  
Date Received12/29/2014
Decision Date 09/18/2015
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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