cobas u 701 microscopy analyzer
FDA 510(k) K200811 · Roche Diagnostics
510(k) numberK200811
Submission
- Device name
- cobas u 701 microscopy analyzer
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- March 27, 2020
- Decision date
- November 6, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKM – Counter, Urine Particle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code LKM
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|---|---|---|---|
| K252580 | iQ200 SeriesLKM · Special | Beckman Coulter, Inc. | 09/10/2025SE |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis SystemLKM · Traditional | Arkray, Inc. | 05/03/2024SE |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemLKM · Traditional | Beckman Coulter, Inc. | 07/02/2021SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | Sysmex America, Inc. | 04/23/2018SE |
| K093861 | Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina CradleLKM · Special | Iris International, Inc. | 02/05/2010SE |
| K083002 | Sysmex UF-500I Automated Urine Particle AnalyzerLKM · Special | Sysmex America, Inc. | 02/03/2009SE |
| K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareLKM · Special | Sysmex America, Inc. | 05/02/2008SE |
| K070910 | Sysmex Model UF1000ILKM · Traditional | Sysmex America, Inc. | 05/25/2007SE |
| K053135 | Sysmex UF-100I Automated Urine Cell AnalyzerLKM · Traditional | Sysmex America, Inc. | 01/04/2006SE |
| K022774 | Iq 200 SystemLKM · Traditional | Intl. Remote Imaging Systems | 10/21/2002SE |
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Questions and answers
When was cobas u 701 microscopy analyzer cleared by the FDA?
cobas u 701 microscopy analyzer (K200811) received a 510(k) decision of Substantially Equivalent on November 6, 2020, 224 days after the submission was received.
What is the product code of K200811?
The FDA product code is LKM – Counter, Urine Particle, a Class II (moderate risk) device regulated under 21 CFR 864.5200.