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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 K143571
Device Name Audit MicroControls Linearity LQ Cystatin-C
Applicant
Aalto Scientific, Ltd.
1959 Kellogg Ave.
Carlsbad,  CA  92008
Applicant Contact ROBERT BURDA
Correspondent
Aalto Scientific, Ltd.
1959 Kellogg Ave.
Carlsbad,  CA  92008
Correspondent Contact ROBERT BURDA
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/17/2014
Decision Date 01/23/2015
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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