SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500— 510(k) K981950
Substantially EquivalentSysmex Corp.
FDA 510(k) clearance K981950 for SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500, Substantially Equivalent on 1998-11-03. Applicant: Sysmex Corp.. Device class: 2.
Clearance details
- Applicant
- Sysmex Corp.
- 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
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