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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K192987
Device Name Aina HbA1c Monitoring System 2
Applicant
Jana Care, Inc.
8 Saint Mary'S St., Suite 936
Boston,  MA  02215
Applicant Contact Michal Depa
Correspondent
MDC Associates, Inc.
180 Cabot St.,
Beverly,  MA  01915
Correspondent Contact Fran White
Regulation Number864.7470
Classification Product Code
LCP  
Date Received10/25/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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