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FDA 510(k)

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

K-Number: K232317 · 2024-04-26

ApplicantUrit Medical Electronic Co., Ltd.
Decision Date2024-04-26
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Urit Medical Electronic Co., Ltd.. The 510(k) number is K232317.

When was UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips approved by the FDA?

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 approval number K232317.

What company makes 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 manufactured by Urit Medical Electronic Co., Ltd..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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