Counter, Urine Particle
FDA product code LKM · 15 cleared devices
Class 2
Hematology
- Regulation
- 21 CFR 864.5200
- Review panel
- HE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1982-10-18 – 2025-09-10
LKM
2025-09-10
LKM
2024-05-03
AUTION EYE AI-4510 Urine Particle Analysis System
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LKM
2021-07-02
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
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LKM
2020-11-06
cobas u 701 microscopy analyzer
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LKM
2018-04-23
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
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LKM
2010-02-05
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
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LKM
2009-02-03
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
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LKM
2008-05-02
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
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LKM
2007-05-25
SYSMEX MODEL UF1000I
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LKM
2006-01-04
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
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LKM
2002-10-21
IQ 200 SYSTEM
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LKM
2001-09-28
SYSMEX UF-50
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LKM
2000-04-14
939UDX URINE PATHOLOGY SYSTEM
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LKM
1996-10-28
SYSMEX UF-100
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LKM
1982-10-18
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
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