OneDraw A1C Test System— 510(k) K183230

Name: FDA 510(k) clearance K183230
Creator: U.S. Food and Drug Administration
Published: 2019-08-15

Substantially Equivalent

Drawbridge Health, Inc.

FDA 510(k) clearance K183230 for OneDraw A1C Test System, Substantially Equivalent on 2019-08-15. Applicant: Drawbridge Health, Inc.. Device class: 2.

Clearance details

Applicant: Drawbridge Health, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2018-11-20
Decision date: 2019-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCP

view all

K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer2024-11-22
K231465 — Q-Pad Test System2023-12-06
K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer2023-09-27
K192987 — Aina HbA1c Monitoring System 22020-03-26
K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2019-10-29

More clearances from Drawbridge Health, Inc.

view all

K223826 — NanoDrop Lancet2024-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.