FDA 510(k)

OneDraw A1C Test System

K-Number: K183230 · 2019-08-15

Decision Date2019-08-15

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

OneDraw A1C Test System is a medical device manufactured by Drawbridge Health, Inc.. It received FDA 510(k) clearance on 2019-08-15 under approval 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. It is manufactured by Drawbridge Health, Inc.. The 510(k) number is K183230.

When was OneDraw A1C Test System approved by the FDA?

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

What company makes OneDraw A1C Test System?

OneDraw A1C Test System is manufactured by Drawbridge Health, Inc..

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

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

Other Devices by Drawbridge Health, Inc.

K223826NanoDrop Lancet

Related Devices (Code: LCP)

K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDiazyme Laboratories K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics K170147Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes 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.