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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 K082717
Device Name AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-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 Received09/17/2008
Decision Date 10/30/2008
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
Predetermined Change
Control Plan Authorized		 No
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