UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips— 510(k) K232317
Substantially EquivalentUrit Medical Electronic Co., Ltd.
FDA 510(k) clearance K232317 for UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips, Substantially Equivalent on 2024-04-26. Applicant: Urit Medical Electronic Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Urit Medical Electronic Co., Ltd.
- Product code
- Code JIO
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guilin, CN
Recent devices under product code JIO
view all- K111999 — HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
- K111221 — MISSION U500 URINE ANALYZER
- K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
- K083724 — WIENER LAB. URINE STRIP 10 AND 11
- K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.