FDA 510(k)

Green Card Bowie-Dick Test (BD115)

N.º K: K250172 · 2025-02-20

SolicitanteSteritec Products, Inc. (A Getinge Company)

Fecha de decisión2025-02-20

Código de productoJOJ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Green Card Bowie-Dick Test (BD115) is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products, Inc. (A Getinge Company). It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K250172. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Green Card Bowie-Dick Test (BD115)?

Green Card Bowie-Dick Test (BD115) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Steritec Products, Inc. (A Getinge Company). The 510(k) number is K250172.

When did Green Card Bowie-Dick Test (BD115) receive FDA 510(k) clearance?

Green Card Bowie-Dick Test (BD115) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K250172.

Who is the listed applicant for Green Card Bowie-Dick Test (BD115)?

The FDA 510(k) record lists Steritec Products, Inc. (A Getinge Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Green Card Bowie-Dick Test (BD115)?

The FDA product code for Green Card Bowie-Dick Test (BD115) is JOJ.

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Fuente oficial

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