K232317 is an FDA 510(k) clearance for the UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips. This device is classified as 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 FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K232317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JIO - Blood, Occult, Colorimetric, In Urine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |