Source document or public record
FDA 510(k) K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
FDA 510(k) index record K232317. Device: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips. Applicant as listed: Urit Medical Electronic Co., Ltd.. Decision date: 2024-04-26.
Source
"device_name": "UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K232317.
Device name: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips. Applicant as listed: Urit Medical Electronic Co., Ltd..
Decision date: 2024-04-26. Decision wording: Substantially Equivalent.
Product code: JIO. Regulation: 21 CFR 864.6550. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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