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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
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