Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device— 510(k) K182062
Substantially EquivalentSysmex America, Inc.
FDA 510(k) clearance K182062 for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device, Substantially Equivalent on 2018-10-30. Applicant: Sysmex America, Inc.. Device class: 2.
Clearance details
- Applicant
- Sysmex America, Inc.
- Product code
- Code JOY
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
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More clearances from Sysmex America, Inc.
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- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Data sourced from openFDA. This site is unofficial and independent of the FDA.