FDA 510(k)

Reagente ACE Hemoglobina A1c (HbA1c)

Número K: K170623 · 2018-02-27

RequerenteAlfa Wassermann Diagnostic Technologies, LLC

Data da decisão2018-02-27

Código do produtoLCP

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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