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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K030804
Device Name BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
Original Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown,  NY  10591 5097
Original Contact andres holle
Regulation Number862.1150
Classification Product Code
JIX  
Date Received03/13/2003
Decision Date 04/10/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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