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FDA 510(k)

ACE Hemoglobin A1c (HbA1c) Reagent

K-Number: K170623 · 2018-02-27

ApplicantAlfa Wassermann Diagnostic Technologies, LLC
Decision Date2018-02-27
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACE Hemoglobin A1c (HbA1c) Reagent is a medical device manufactured by Alfa Wassermann Diagnostic Technologies, LLC. It received FDA 510(k) clearance on 2018-02-27 under approval number K170623. 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 ACE Hemoglobin A1c (HbA1c) Reagent?

ACE Hemoglobin A1c (HbA1c) Reagent is a medical device that received FDA 510(k) clearance on 2018-02-27. It is manufactured by Alfa Wassermann Diagnostic Technologies, LLC. The 510(k) number is K170623.

When was ACE Hemoglobin A1c (HbA1c) Reagent approved by the FDA?

ACE Hemoglobin A1c (HbA1c) Reagent received FDA 510(k) clearance on 2018-02-27, under approval number K170623.

What company makes ACE Hemoglobin A1c (HbA1c) Reagent?

ACE Hemoglobin A1c (HbA1c) Reagent is manufactured by Alfa Wassermann Diagnostic Technologies, LLC.

What is the FDA product code for ACE Hemoglobin A1c (HbA1c) Reagent?

The FDA product code for ACE Hemoglobin A1c (HbA1c) Reagent is LCP.

Related Clinical Trials

NCT07509060 HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability ACTIVE_NOT_RECRUITING

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.

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