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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K090900
Device Name ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
Applicant
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number862.3200
Classification Product Code
DKB  
Date Received04/01/2009
Decision Date 06/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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