FDA 510(k)

GAL-1A Plus Blood Glucose Monitoring System

Número K: K213887 · 2022-03-29

Data da decisão2022-03-29

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

GAL-1A Plus Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2022-03-29 under 510(k) number K213887. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GAL-1A Plus Blood Glucose Monitoring System?

GAL-1A Plus Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K213887.

When did GAL-1A Plus Blood Glucose Monitoring System receive FDA 510(k) clearance?

GAL-1A Plus Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-03-29, under 510(k) number K213887.

Who is the listed applicant for GAL-1A Plus Blood Glucose Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAL-1A Plus Blood Glucose Monitoring System?

The FDA product code for GAL-1A Plus Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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