Cleared Traditional

OneDraw A1C Test System

K183230 · Drawbridge Health, Inc. · Chemistry

Aug 2019

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K183230 is an FDA 510(k) clearance for the OneDraw A1C Test System, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Drawbridge Health, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 2019, 268 days after receiving the submission on November 20, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K183230 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2018
Decision Date	August 15, 2019
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF