Identifiers
- 510(k) Number
- K070910 FDA 510(k)
- FDA Product Code
- LKM 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 Model UF1000I is a urine particle counter used in hematology for automated analysis of urine samples. It is designed to detect and count various particles in urine, including red blood cells, white blood cells, bacteria, and other formed elements.
This device is supplied by Sysmex America, Inc. and is intended for laboratory use. It is a Class II medical device cleared by the FDA through a 510(k) process with product code LKM. The device is not specified as single-use or reusable, and no information regarding MRI safety or sterility is provided in the data.
Frequently asked questions
What is the Sysmex Model UF1000I used for?
The Sysmex Model UF1000I is a urine particle counter used in hematology for automated analysis of urine samples. It detects and counts various particles including red blood cells, white blood cells, bacteria, and other formed elements.
How is the Sysmex UF1000I supplied?
The device is supplied by Sysmex America, Inc. and is intended for laboratory use. The data does not specify whether it is single-use or reusable, nor does it provide information regarding sterility or MRI safety.
What is the regulatory status of the Sysmex UF1000I?
The Sysmex Model UF1000I is a Class II medical device cleared by the FDA through a 510(k) process with product code LKM. It was determined to be substantially equivalent to predicate devices and received clearance on May 25, 2007.
What sizes or models of the Sysmex UF1000I are available?
The device data only references the Sysmex Model UF1000I without mentioning different sizes or models. The K number for this device is K070910, which distinguishes it in regulatory submissions.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070910 | Class II | Active |
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Manufacturer
- Manufacturer
- Sysmex America, Inc.
Sources (1)
- FDA 510(k) K070910 24 fields · synced Sep 21, 2026