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FDA 510(k)

Her-2, ER, PR IHControls

N.º K: K220163 · 2022-08-15

SolicitanteBoston Cell Standards, Inc.
Fecha de decisión2022-08-15
Código de productoNJW
Comité asesorHE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Her-2, ER, PR IHControls is the device name listed in this FDA 510(k) record. The listed applicant is Boston Cell Standards, Inc.. It received FDA 510(k) clearance on 2022-08-15 under 510(k) number K220163. The device is classified under product code NJW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Her-2, ER, PR IHControls?

Her-2, ER, PR IHControls is a medical device that received FDA 510(k) clearance on 2022-08-15. The listed applicant is Boston Cell Standards, Inc.. The 510(k) number is K220163.

When did Her-2, ER, PR IHControls receive FDA 510(k) clearance?

Her-2, ER, PR IHControls received FDA 510(k) clearance on 2022-08-15, under 510(k) number K220163.

Who is the listed applicant for Her-2, ER, PR IHControls?

The FDA 510(k) record lists Boston Cell Standards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Her-2, ER, PR IHControls?

The FDA product code for Her-2, ER, PR IHControls is NJW.

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Fuente oficial

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