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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
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact ANDRES HOLLE
Correspondent
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact ANDRES HOLLE
Regulation Number862.1150
Classification Product Code
JIX  
Date Received03/13/2003
Decision Date 04/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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