SYSMEX R-500— 510(k) K001683
Substantially EquivalentSysmex Corporation of America
FDA 510(k) clearance K001683 for SYSMEX R-500, Substantially Equivalent on 2000-08-21. Applicant: Sysmex Corporation of America. Device class: 2.
Clearance details
- Applicant
- Sysmex Corporation of America
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Long Grove, IL, US
Recent devices under product code GKL
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