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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K161874
Device Name Audit MicroControls Linearity DROP LQ Blood Glucose
Applicant
Aalto Scientific, Ltd.
230 Technology Pkwy.
Eatonton,  GA  30642
Applicant Contact ROBERT BURDA
Correspondent
Aalto Scientific, Ltd.
230 Technology Pkwy.
Eatonton,  GA  30642
Correspondent Contact ROBERT BURDA
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/08/2016
Decision Date 08/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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