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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K121759
Device Name CONE-TROL LIQUID CHEMISTRY CONTROLS
Original Applicant
CONE BIOPRODUCTS
1012 n austin st
seguin,  TX  78155
Original Contact will cone
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/15/2012
Decision Date 07/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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