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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K083386
Device Name ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
Applicant
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Applicant Contact CAROL BIANCA
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact CAROL BIANCA
Regulation Number862.1145
Classification Product Code
CJY  
Date Received11/17/2008
Decision Date 04/02/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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