FDA 510(k)

i-STAT G3+ cartridge with the i-STAT 1 System

Número K: K223857 · 2023-09-15

Data da decisão2023-09-15

Código do produtoCHL

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

i-STAT G3+ 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 2023-09-15 under 510(k) number K223857. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the i-STAT G3+ cartridge with the i-STAT 1 System?

i-STAT G3+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K223857.

When did i-STAT G3+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT G3+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-09-15, under 510(k) number K223857.

Who is the listed applicant for i-STAT G3+ 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 G3+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT G3+ cartridge with the i-STAT 1 System is CHL.

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Fonte oficial

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