Cleared Traditional

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

K232317 · Urit Medical Electronic Co., Ltd. · Chemistry

Apr 2024

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K232317 is an FDA 510(k) clearance for the UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips, a Blood, Occult, Colorimetric, In Urine (Class II — Special Controls, product code JIO), submitted by Urit Medical Electronic Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on April 26, 2024, 267 days after receiving the submission on August 3, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K232317 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2023
Decision Date	April 26, 2024
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF