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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K952720
Device Name AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
Applicant
Aalto Scientific, Ltd.
1160 Joshua Way
Vista,  CA  92083
Applicant Contact KEVIN JONES
Correspondent
Aalto Scientific, Ltd.
1160 Joshua Way
Vista,  CA  92083
Correspondent Contact KEVIN JONES
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/15/1995
Decision Date 09/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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