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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 K183230
Device Name OneDraw A1C Test System
Applicant
Drawbridge Health, Inc.
11535 Sorrrento Valley Road, Suite 407
San Diego,  CA  92121
Applicant Contact Annie Wright
Correspondent
Drawbridge Health, Inc.
11535 Sorrrento Valley Road, Suite 407
San Diego,  CA  92121
Correspondent Contact Annie Wright
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
PRJ  
Date Received11/20/2018
Decision Date 08/15/2019
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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