FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sysmex XN-L Automated Hematology Analyzer
K Number: K182389
·
Decision Jan 25, 2019
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
31
Review Days
143
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Basic Information
- Device Name
- Sysmex XN-L Automated Hematology Analyzer
- K Number
- K182389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sysmex America, Inc.
- Date Received
- September 4, 2018
- Decision Date
- January 25, 2019
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by Sysmex America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | May 27, 2026 | Substantially Equivalent |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Jun 25, 2025 | Substantially Equivalent |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Jun 25, 2025 | Substantially Equivalent |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Jun 2, 2025 | Substantially Equivalent |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Dec 21, 2023 | Substantially Equivalent |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Nov 8, 2022 | Substantially Equivalent |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Oct 30, 2018 | Substantially Equivalent |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Apr 23, 2018 | Substantially Equivalent |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Nov 6, 2017 | Substantially Equivalent |
| K160538 | Sysmex XN-L Automated Hematology Analyzer | Dec 22, 2016 | Substantially Equivalent |