FDA 510(k)

GlutenID Celiac Genetic Health Risk Test

N.º K: K241456 · 2025-01-07

Fecha de decisión2025-01-07

Código de productoPTA

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

GlutenID Celiac Genetic Health Risk Test is the device name listed in this FDA 510(k) record. The listed applicant is Targeted Genomics, LLC. It received FDA 510(k) clearance on 2025-01-07 under 510(k) number K241456. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GlutenID Celiac Genetic Health Risk Test?

GlutenID Celiac Genetic Health Risk Test is a medical device that received FDA 510(k) clearance on 2025-01-07. The listed applicant is Targeted Genomics, LLC. The 510(k) number is K241456.

When did GlutenID Celiac Genetic Health Risk Test receive FDA 510(k) clearance?

GlutenID Celiac Genetic Health Risk Test received FDA 510(k) clearance on 2025-01-07, under 510(k) number K241456.

Who is the listed applicant for GlutenID Celiac Genetic Health Risk Test?

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

What is the FDA product code for GlutenID Celiac Genetic Health Risk Test?

The FDA product code for GlutenID Celiac Genetic Health Risk Test is PTA.

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Dispositivos relacionados (Código: PTA)

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Fuente oficial

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