SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER— 510(k) K083002
Substantially EquivalentSysmex America, Inc.
FDA 510(k) clearance K083002 for SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER, Substantially Equivalent on 2009-02-03. 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
- Special
- Location
- Mundelein, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.