Sysmex POCH-100I
FDA 510(k) K032677 · Sysmex America, Inc.
510(k) numberK032677
Submission
- Device name
- Sysmex POCH-100I
- Applicant
- Sysmex America, Inc.
Mundelein, IL, US - Received
- August 29, 2003
- Decision date
- February 11, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code GKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | Advanced Instruments, Inc. | 05/27/2016SE |
| K091539 | Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional | Iris Diagnostics | 08/31/2010SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | Hemocue AB | 10/25/2007SE |
| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional | Bayer Healthcare, LLC | 12/07/2005SE |
| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | Sysmex Corp. | 11/03/1998SE |
| K981761 | Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional | Sysmex Corp. | 08/14/1998SE |
More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | 05/27/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional | 06/02/2025SE |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional | 12/21/2023SE |
| K210346 | Sysmex XW-100 Automated Hematology AnalyzerGKZ · Dual Track | 11/08/2022SE |
| K182389 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 01/25/2019SE |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional | 10/30/2018SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | 04/23/2018SE |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ · Dual Track | 11/06/2017SE |
Questions and answers
When was Sysmex POCH-100I cleared by the FDA?
Sysmex POCH-100I (K032677) received a 510(k) decision of Substantially Equivalent on February 11, 2004, 166 days after the submission was received.
What is the product code of K032677?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.