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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K100778
Device Name DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ROSE T MARINELLI
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ROSE T MARINELLI
Regulation Number862.1150
Classification Product Code
JIX  
Date Received03/19/2010
Decision Date 05/05/2010
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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