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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K091867
Device Name ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
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 Number862.1680
Classification Product Code
CDZ  
Subsequent Product Codes
JIT   JJX  
Date Received06/23/2009
Decision Date 01/14/2010
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
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