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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 the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, LLC. It received FDA 510(k) clearance on 2018-02-27 under 510(k) 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. The listed applicant is Alfa Wassermann Diagnostic Technologies, LLC. The 510(k) number is K170623.

When did ACE Hemoglobin A1c (HbA1c) Reagent receive FDA 510(k) clearance?

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

Who is the listed applicant for ACE Hemoglobin A1c (HbA1c) Reagent?

The FDA 510(k) record lists Alfa Wassermann Diagnostic Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07509060HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological VulnerabilityACTIVE_NOT_RECRUITINGNCT07714759A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition InterventionNOT_YET_RECRUITING

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.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

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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