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FDA 510(k)

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

Número K: K232317 · 2024-04-26

RequerenteUrit Medical Electronic Co., Ltd.
Data da decisão2024-04-26
Código do produtoJIO
Comité consultivoHE
DecisãoSubstantially Equivalent

Resumo do dispositivo

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips is the device name listed in this FDA 510(k) record. The listed applicant is Urit Medical Electronic Co., Ltd.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K232317. The device is classified under product code JIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips?

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Urit Medical Electronic Co., Ltd.. The 510(k) number is K232317.

When did UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips receive FDA 510(k) clearance?

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips received FDA 510(k) clearance on 2024-04-26, under 510(k) number K232317.

Who is the listed applicant for UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips?

The FDA 510(k) record lists Urit Medical Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips?

The FDA product code for UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips is JIO.

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Fonte oficial

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