ClearanceBrief
510(k) K022774 ยท LKM Counter, Urine Particle

IQ 200 SYSTEM

ApplicantIntl. Remote Imaging Systems, Chatsworth CA, US
DecisionSubstantially Equivalent, Oct 21, 2002
ReceivedAug 21, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K022774

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Beckman Coulter, Inc.
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Open, Classified		 KQONone listed
Oct 15, 2026Beckman Coulter, Inc.
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B4899
Open, Classified		 KQONone listed
Jan 25, 2024Beckman Coulter, Inc.
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Open, Classified		 LKMNone listed
Jan 25, 2024Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
Open, Classified		 LKMNone listed
Jan 25, 2024Beckman Coulter, Inc.
REV 2 Flowcell Capsule Spare, Part Number: C04154
Open, Classified		 LKMNone listed
Jan 25, 2024Beckman Coulter, Inc.
iQ Waste Well Adapter, Part Number: 700-3393
Open, Classified		 LKMNone listed
May 17, 2023Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Se
Open, Classified		 KQONone listed
May 17, 2023Beckman Coulter, Inc.
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Open, Classified		 KQONone listed
May 17, 2023Beckman Coulter, Inc.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Open, Classified		 KQONone listed
May 17, 2023Beckman Coulter, Inc.
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Open, Classified		 KQONone listed
May 9, 2020Beckman Coulter Inc.
iQ200 Series Urine Microscopy Analyzer- All part numbers
Terminated		 KQONone listed
Oct 28, 2019Beckman Coulter Inc.
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10
Terminated		 LKMNone listed
Mar 2, 2018Beckman Coulter Inc.
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
Terminated		 KQONone listed
Nov 10, 2017Beckman Coulter Inc.
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800
Terminated		 KQONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.