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FDA 510(k)

OneDraw A1C Test System

K-Number: K183230 · 2019-08-15

ApplicantDrawbridge Health, Inc.
Decision Date2019-08-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OneDraw A1C Test System is the device name listed in this FDA 510(k) record. The listed applicant is Drawbridge Health, Inc.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K183230. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OneDraw A1C Test System?

OneDraw A1C Test System is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Drawbridge Health, Inc.. The 510(k) number is K183230.

When did OneDraw A1C Test System receive FDA 510(k) clearance?

OneDraw A1C Test System received FDA 510(k) clearance on 2019-08-15, under 510(k) number K183230.

Who is the listed applicant for OneDraw A1C Test System?

The FDA 510(k) record lists Drawbridge Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneDraw A1C Test System?

The FDA product code for OneDraw A1C Test System is LCP.

Other records listing Drawbridge Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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