FDA 510(k)

i-STAT Alinity System with i-STAT Sodium test

Número K: K153357 · 2016-07-08

Data da decisão2016-07-08

Código do produtoJGS

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

i-STAT Alinity System with i-STAT Sodium test 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 2016-07-08 under 510(k) number K153357. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the i-STAT Alinity System with i-STAT Sodium test?

i-STAT Alinity System with i-STAT Sodium test is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K153357.

When did i-STAT Alinity System with i-STAT Sodium test receive FDA 510(k) clearance?

i-STAT Alinity System with i-STAT Sodium test received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153357.

Who is the listed applicant for i-STAT Alinity System with i-STAT Sodium test?

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 Alinity System with i-STAT Sodium test?

The FDA product code for i-STAT Alinity System with i-STAT Sodium test is JGS.

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Fonte oficial

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