FDA 510(k)

Healgen URS Test Strips

N.º K: K231045 · 2023-06-16

Fecha de decisión2023-06-16

Código de productoLJX

Comité asesorHE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Healgen URS Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K231045. The device is classified under product code LJX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Healgen URS Test Strips?

Healgen URS Test Strips is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K231045.

When did Healgen URS Test Strips receive FDA 510(k) clearance?

Healgen URS Test Strips received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231045.

Who is the listed applicant for Healgen URS Test Strips?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen URS Test Strips?

The FDA product code for Healgen URS Test Strips is LJX.

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Otros registros que enlistan a Healgen Scientific,, LLC como solicitante

K260095Heal-Check Rapid COVID-19 Antigen Self-Test K253705Healgen® Accurate Oral Fluid Drug Test K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card K251800Healgen® URS Test Strips K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.