# Sysmex Corp.

- Location (FDA's records): Long Grove, IL
- FDA decisions: 18 (1979–2001): 18 510(k) clearances
- Product codes: GKZ (4), GKL (4), JPA (3), LKM (2), GIF (1), FPK (1), JRQ (1), GGK (1), GKR (1)
- Predicates its devices cite: 13 (5 its own); citations of its devices by later devices: 13 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Toa Medical Electronics USA, Inc.: 6 (https://510kreport.com/company/toa-medical-electronics-usa)
- Streck Laboratories, Inc.: 2 (https://510kreport.com/company/streck-laboratories)

## Firms that cite its devices most
- Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/mindray-bio-medical-electronics)
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Coulter Corp.: 1 (https://510kreport.com/company/coulter)
- Sysmex Corporation of America: 1 (https://510kreport.com/company/sysmex-of-america)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)
- Abx Diagnostics: 1 (https://510kreport.com/company/abx-diagnostics)
- Pointcare Technologies, Inc.: 1 (https://510kreport.com/company/pointcare-technologies)

## Its most-cited devices
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer (1999), cited by 5
- K971736: Sysmex Immature Reticulocyte Fraction (Irf) Parameter (1997), cited by 2
- K964375: Sysmex SE/Ram-1 (1997), cited by 2
- K942097: Toa Medical Electronics CA-5000 (1995), cited by 1
- K950508: Sysmex SF-3000 (1995), cited by 1
- K942096: Toa Medical Electronics CA-1000 (1995), cited by 1

## Recent decisions
- K012372: Sysmex UF-50 (Sep 28, 2001)
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer (Nov 9, 1999)
- K981950: Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500 (Nov 3, 1998)
- K981761: Sysmex KX-21, Automated Hematology Analyzer (Aug 14, 1998)
- K971736: Sysmex Immature Reticulocyte Fraction (Irf) Parameter (Aug 26, 1997)
- K964946: Sysmex CA-1000/Sysmex CA-5000 (Mar 18, 1997)
- K964375: Sysmex SE/Ram-1 (Mar 13, 1997)
- K961054: Sysmex UF-100 (Oct 28, 1996)

Source page: https://510kreport.com/company/sysmex