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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 K100718
Device Name AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
Applicant
Aalto Scientific, Ltd.
1959 Kellogg Ave.
Carlsbad,  CA  92008
Applicant Contact BRANDON J PEREZ
Correspondent
Aalto Scientific, Ltd.
1959 Kellogg Ave.
Carlsbad,  CA  92008
Correspondent Contact BRANDON J PEREZ
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/12/2010
Decision Date 09/03/2010
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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