SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER— 510(k) K053135
Substantially EquivalentSysmex America, Inc.
FDA 510(k) clearance K053135 for SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER, Substantially Equivalent on 2006-01-04. Applicant: Sysmex America, Inc.. Device class: 2.
Clearance details
- Applicant
- Sysmex America, Inc.
- Product code
- Code LKM
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
Recent devices under product code LKM
view allMore clearances from Sysmex America, Inc.
view all- K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- 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.