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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 K030169
Device Name SETPOINT CHEMISTRY 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 Received01/17/2003
Decision Date 01/31/2003
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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