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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plasma, coagulation control
510(k) Number K100716
Device Name AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
Applicant
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD,  CA  92008
Applicant Contact DESSI LYAKOV
Correspondent
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD,  CA  92008
Correspondent Contact DESSI LYAKOV
Regulation Number864.5425
Classification Product Code
GGN  
Date Received03/12/2010
Decision Date 06/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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