FDA 510(k)

i-STAT CG8+ cartridge with the i-STAT 1 System

N.º K: K230275 · 2023-10-27

Fecha de decisión2023-10-27

Código de productoJGS

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

i-STAT CG8+ cartridge with the i-STAT 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K230275. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the i-STAT CG8+ cartridge with the i-STAT 1 System?

i-STAT CG8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K230275.

When did i-STAT CG8+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT CG8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-10-27, under 510(k) number K230275.

Who is the listed applicant for i-STAT CG8+ cartridge with the i-STAT 1 System?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-STAT CG8+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT CG8+ cartridge with the i-STAT 1 System is JGS.

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Otros registros que enlistan a Abbott Point of Care, Inc. como solicitante

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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.