510(k) K022774
- Device
- IQ 200 SYSTEM
- Applicant
- INTL. REMOTE IMAGING SYSTEMS
- 510(k) number
- K022774
- Product code
- LKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-21
- Date received
- 2002-08-21
- Regulation
- 864.5200
- Classification name
- Counter, Urine Particle
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARVEY L KASDAN
- Address
- 9162 Eton Ave. Chatsworth CA US 91311 91311
FDA Registration Numbers#
- 9611444
- 9613959
- 1061932
- 3006198300
- 3010421384
- 3007701696
- 1832816
- 3009711478
- 3020704087
- 3010960914
- 2122870
- 3003422726
Source Documents#
Other 510(k) Records For Product Code LKM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025-09-10 |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | 2024-05-03 |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021-07-02 |
| K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics | 2020-11-06 |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | 2018-04-23 |
| K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | Iris International, Inc. | 2010-02-05 |
| K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | Sysmex America, Inc. | 2009-02-03 |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | Sysmex America, Inc. | 2008-05-02 |
| K070910 | SYSMEX MODEL UF1000I | Sysmex America, Inc. | 2007-05-25 |
| K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | Sysmex America, Inc. | 2006-01-04 |
| K012372 | SYSMEX UF-50 | Sysmex Corp. | 2001-09-28 |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 2000-04-14 |
| K961054 | SYSMEX UF-100 | Sysmex Corp. | 1996-10-28 |
| K822823 | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | Eko Scann AB | 1982-10-18 |
Legacy Summary#
summary
FDA Review#
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