SYSMEX SF-3000— 510(k) K950508
Substantially EquivalentSysmex Corp.
FDA 510(k) clearance K950508 for SYSMEX SF-3000, Substantially Equivalent on 1995-11-03. Applicant: Sysmex Corp.. Device class: 2.
Clearance details
- Applicant
- Sysmex Corp.
- Product code
- Code FPK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Long Grove, IL, US
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More clearances from Sysmex Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.