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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K103548
Device Name ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
Applicant
Siemens Healthcare Diagnostics Inc.
333 CONEY STREET
EAST WALPOLE,  MA  02032
Applicant Contact Sandra D White
Correspondent
Siemens Healthcare Diagnostics Inc.
333 CONEY STREET
EAST WALPOLE,  MA  02032
Correspondent Contact Sandra D White
Regulation Number862.1150
Classification Product Code
JIT  
Date Received12/03/2010
Decision Date 06/02/2011
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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