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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 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.

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. 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.

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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