SYSMEX XN-SERIES— 510(k) K112605
Substantially EquivalentSysmex America, Inc.
FDA 510(k) clearance K112605 for SYSMEX XN-SERIES, Substantially Equivalent on 2012-10-19. Applicant: Sysmex America, Inc.. Device class: 2.
Clearance details
- Applicant
- Sysmex America, Inc.
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
Recent devices under product code GKZ
view allMore clearances from Sysmex America, Inc.
view all- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112605
K-number listed on FDA's recall record- Z-2034-2017 — Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
- Z-1945-2016 — The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112605.
Data sourced from openFDA. This site is unofficial and independent of the FDA.