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510(k) K183230

OneDraw A1C Test System by Drawbridge Health, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2019
Date Received
November 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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