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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, serological, positive control
510(k) Number K101434
Device Name AUDIT MICROCV PROCALCITONIN LINEARITY
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 Number862.1660
Classification Product Code
MJX  
Date Received05/21/2010
Decision Date 07/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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