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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K093939
Device Name ADVIA CHEMISTRY SALICYLATE REAGENT
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received12/22/2009
Decision Date 05/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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