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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 K112705
Device Name AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
Original Applicant
AALTO SCIENTIFIC LTD.
1959 kellogg ave.
carlsbad,  CA  92008
Original Contact dessi lyakov
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/19/2011
Decision Date 01/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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