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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 K031682
Device Name LIPOPROTEIN CALIBRATOR
Original Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown,  NY  10591
Original Contact kenneth t edds
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/30/2003
Decision Date 06/25/2003
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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