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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hematocrit
510(k) Number K020618
Device Name AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
Applicant
Aalto Scientific, Ltd.
1959 Kellogg Ave.
Carlsbad,  CA  92008
Applicant Contact KENNETH GAUTHIER
Correspondent
Aalto Scientific, Ltd.
1959 Kellogg Ave.
Carlsbad,  CA  92008
Correspondent Contact KENNETH GAUTHIER
Regulation Number864.8625
Classification Product Code
GLK  
Date Received02/25/2002
Decision Date 05/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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