Atlas FDA

LKM

15 FDA 510(k) clearances · Product code

64 daysmedian time to decision
266 days90th percentile
15clearances measured

FDA profile

Official device name
Counter, Urine Particle
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5200
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
iQ200 Series (K252580)Beckman Coulter, Inc.2025-09-10
AUTION EYE AI-4510 Urine Particle Analysis System (K232416)Arkray, Inc.2024-05-03
iQ200 System, iChemVELOCITY Automated Urine Chemistry System (K210127)Beckman Coulter, Inc.2021-07-02
cobas u 701 microscopy analyzer (K200811)Roche Diagnostics2020-11-06
Sysmex UF-5000 Fully Automated Urine Particle Analyzer (K171883)Sysmex America, Inc.2018-04-23
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (K093861)Iris International, Inc.2010-02-05
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (K083002)Sysmex America, Inc.2009-02-03
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887)Sysmex America, Inc.2008-05-02
SYSMEX MODEL UF1000I (K070910)Sysmex America, Inc.2007-05-25
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (K053135)Sysmex America, Inc.2006-01-04
IQ 200 SYSTEM (K022774)Intl. Remote Imaging Systems2002-10-21
SYSMEX UF-50 (K012372)Sysmex Corp.2001-09-28
939UDX URINE PATHOLOGY SYSTEM (K000373)Intl. Remote Imaging Systems2000-04-14
SYSMEX UF-100 (K961054)Sysmex Corp.1996-10-28
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT (K822823)Eko Scann AB1982-10-18

Track LKM automatically

Every clearance here is in the API, with alerts when new ones post.