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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 K032122
Device Name AUDIT MICROCONTROLS MICROFD BNP CONTROL
Applicant
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD,  CA  92008
Applicant Contact ALAN J VEKICH
Correspondent
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD,  CA  92008
Correspondent Contact ALAN J VEKICH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/09/2003
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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