FDA 510(k)

Hipro Glycosylated Hemoglobin (HbA1c) Test System

N.º K: K220999 · 2024-09-12

SolicitanteShijiazhuang Hipro Biotechnology Co., Ltd.

Fecha de decisión2024-09-12

Código de productoPDJ

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hipro Glycosylated Hemoglobin (HbA1c) Test System is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Hipro Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K220999. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hipro Glycosylated Hemoglobin (HbA1c) Test System?

Hipro Glycosylated Hemoglobin (HbA1c) Test System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Shijiazhuang Hipro Biotechnology Co., Ltd.. The 510(k) number is K220999.

When did Hipro Glycosylated Hemoglobin (HbA1c) Test System receive FDA 510(k) clearance?

Hipro Glycosylated Hemoglobin (HbA1c) Test System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K220999.

Who is the listed applicant for Hipro Glycosylated Hemoglobin (HbA1c) Test System?

The FDA 510(k) record lists Shijiazhuang Hipro Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System?

The FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System is PDJ.

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