FDA 510(k)

inui In-Home Urine Analysis Test System

Número K: K180356 · 2018-05-25

Data da decisão2018-05-25

Código do produtoJIL

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

inui In-Home Urine Analysis Test System is the device name listed in this FDA 510(k) record. The listed applicant is Scanadu, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K180356. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the inui In-Home Urine Analysis Test System?

inui In-Home Urine Analysis Test System is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Scanadu, Inc.. The 510(k) number is K180356.

When did inui In-Home Urine Analysis Test System receive FDA 510(k) clearance?

inui In-Home Urine Analysis Test System received FDA 510(k) clearance on 2018-05-25, under 510(k) number K180356.

Who is the listed applicant for inui In-Home Urine Analysis Test System?

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

What is the FDA product code for inui In-Home Urine Analysis Test System?

The FDA product code for inui In-Home Urine Analysis Test System is JIL.

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