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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 K163629
Device Name Audit MicroControls Linearity FD Tumor Markers II
Applicant
Aalto Scientific, Ltd.
230 Technology Parkway
Eatonton,  GA  31024
Applicant Contact Robert Burda
Correspondent
Aalto Scientific, Ltd.
230 Technology Parkway
Eatonton,  GA  31024
Correspondent Contact Robert Burda
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/22/2016
Decision Date 03/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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