K232317
- 510(k) number
- K232317
- Device name
- UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
- Applicant
- Urit Medical Electronic Co., Ltd. CN
- Product code
- JIO — Blood, Occult, Colorimetric, In Urine
- Decision date
- 2024-04-26
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K232317.pdf
Official FDA record: K232317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.