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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K091123
Device Name ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Applicant Contact CLARE SANTULLI
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact CLARE SANTULLI
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/17/2009
Decision Date 08/14/2009
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
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