Hematology Computer-Interface, Viscount
FDA 510(k) K822823 · Eko Scann AB
510(k) numberK822823
Submission
- Device name
- Hematology Computer-Interface, Viscount
- Applicant
- Eko Scann AB
Mchenry, IL, US - Received
- September 21, 1982
- Decision date
- October 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K200811 | cobas u 701 microscopy analyzerLKM · Traditional | Roche Diagnostics | 11/06/2020SE |
| 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 |
More from Sysmex America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822873 | DevethermDQB · Traditional | 03/24/1983SE |
Questions and answers
When was Hematology Computer-Interface, Viscount cleared by the FDA?
Hematology Computer-Interface, Viscount (K822823) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 27 days after the submission was received.
What is the product code of K822823?
The FDA product code is LKM – Counter, Urine Particle, a Class II (moderate risk) device regulated under 21 CFR 864.5200.