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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 K072204
Device Name ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
Applicant
Siemens Medical Solutions Diagnostics
511 Benedict Ave.
New York,  NY  10591
Applicant Contact PHILIP LIU
Correspondent
Siemens Medical Solutions Diagnostics
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact PHILIP LIU
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/08/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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