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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 K103701
Device Name ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/20/2010
Decision Date 02/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
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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