SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS— 510(k) K850171
Substantially EquivalentToa Medical Electronics USA, Inc.
FDA 510(k) clearance K850171 for SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS, Substantially Equivalent on 1985-05-13. Applicant: Toa Medical Electronics USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Toa Medical Electronics USA, Inc.
- 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
- Carson, CA, US
Recent devices under product code GKL
view allMore clearances from Toa Medical Electronics USA, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.