Sysmex KX-21 Automated Hematology Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Sysmex Corp.
Identifiers
- 510(k) Number
- K981761 FDA 510(k)
- FDA Product Code
- GKL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5200 FDA 510(k)
- Regulation Number
- 864.5200 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sysmex Kx-21 is an automated hematology analyzer designed for use as a cell counter. It functions as an automated particle counter to assist in laboratory hematology analysis.
This device is identified by K-number K981761 and has received FDA 510(k) clearance. It is classified under regulation number 864.5200 as a laboratory instrument.
Frequently asked questions
What is the primary function of the Sysmex KX-21?
The Sysmex KX-21 is an automated hematology analyzer designed to function as a cell counter. It is used to assist in laboratory hematology analysis by providing automated particle counting.
What is the regulatory status of this device?
The Sysmex KX-21 has received FDA 510(k) clearance under K-number K981761. It is classified as a laboratory instrument under regulation number 864.5200.
How is the Sysmex KX-21 classified for regulatory purposes?
The device is classified as a Class 2 automated particle counter under the hematology medical specialty. It is categorized under product code GKL and regulation number 864.5200.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Willkommen - Sysmex Deutschland GmbH, SYSMEX KX-21 OPERATOR'S MANUAL Pdf Download | ManualsLib, Sysmex Europe, Sysmex KX-21 Manuals | ManualsLib, Sysmex Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981761 | Class II | Active |
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Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA 510(k) K981761 24 fields · synced Sep 21, 2026